Johnson & Johnson Clinical Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 33 510(k) clearances under the applicant name “Johnson & Johnson Clinical Diagnostics, Inc.” (first 1995, latest 1998), across 27 product codes in 3 review panels. Median 510(k) review time under this name: 39 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under QuidelOrtho, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 3 | 3 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 2 | 2 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 2 | 2 |
| DHA | System, Test, Human Chorionic Gonadotropin | 2 | 2 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 2 | 2 |
| CDN | Urease, Photometric, Urea Nitrogen | 1 | 1 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 | 1 |
| CEE | Radioimmunoassay, Thyroxine-Binding Globulin | 1 | 1 |
| CEM | Electrode, Ion Specific, Potassium | 1 | 1 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 | 1 |
Plus 17 more product codes.
Review panels
- Clinical Chemistry (29)
- Immunology (2)
- Clinical Toxicology (2)
Most recent Johnson & Johnson Clinical Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K980283 | VITROS CHEMISTRY PRODUCTS CRBM SLIDES | KLT | 1998-02-25 | 30 |
| K974644 | VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS | JJX | 1998-01-13 | 32 |
| K973517 | VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS | JJY | 1997-09-25 | 8 |
| K973030 | VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300) | JJY | 1997-09-04 | 21 |
| K972133 | VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070) | JLS | 1997-06-24 | 18 |
| K970894 | VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL B-HCG CALIBRATORS (GEM.C075) | DHA | 1997-04-14 | 34 |
| K970643 | VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050) | CHP | 1997-03-18 | 26 |
| K965142 | VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15) | CEC | 1997-03-18 | 85 |
| K970281 | VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS | CFT | 1997-02-25 | 32 |
| K964982 | VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55) | CEP | 1997-02-20 | 70 |
23 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Johnson & Johnson Clinical Diagnostics, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Johnson & Johnson Professionals, Inc. (206 510(k)s)
- Johnson & Johnson Medical, Inc. (53 510(k)s)
- Johnson & Johnson Orthopaedics, Inc. (22 510(k)s)
- Johnson & Johnson (14 510(k)s)
- Johnson & Johnson Vision Care, Inc. (12 510(k)s)
- Johnson & Johnson International (10 510(k)s)
- Johnson & Johnson Consumer Products, Inc. (8 510(k)s)
- Johnson & Johnson Medical, Div. of Ethicon, Inc. (5 510(k)s)
- Johnson & Johnson Surgical Vision, Inc. (4 510(k)s)
- Johnson & Johnson Patient Care, Inc. (4 510(k)s)
- Johnson & Johnson Medical, Ltd. (3 510(k)s)
- Johnson & Johnson Consumer, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Johnson & Johnson Clinical Diagnostics, Inc.?
FDA lists 33 510(k) clearances under the applicant name “Johnson & Johnson Clinical Diagnostics, Inc.” (first 1995, latest 1998), across 27 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Johnson & Johnson Clinical Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Johnson & Johnson Clinical Diagnostics, Inc. is 39 days.
Which FDA product codes appear under Johnson & Johnson Clinical Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are JJY (Multi-Analyte Controls, All Kinds (Assayed), 3); CDP (Radioimmunoassay, Total Triiodothyronine, 2); CGJ (Radioimmunoassay, Follicle-Stimulating Hormone, 2).
Next steps
- See all 33 Johnson & Johnson Clinical Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJY, Johnson & Johnson Clinical Diagnostics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.