Ortho Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Ortho Diagnostics, Inc.” (first 1977, latest 1980), across 18 product codes in 5 review panels. Median 510(k) review time under this name: 36 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 |
|---|---|---|---|
| JBQ | Antithrombin Iii Quantitation | 2 | 2 |
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 2 | 2 |
| JPK | Mixture, Hematology Quality Control | 2 | 2 |
| KSF | Kit, Quality Control For Blood Banking Reagents | 2 | 2 |
| KSG | Media, Potentiating For In Vitro Diagnostic Use | 2 | 2 |
| KSX | Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use | 2 | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 | 1 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 | 1 |
| DCF | Albumin, Antigen, Antiserum, Control | 1 | 1 |
| DOG | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol | 1 | 1 |
Plus 8 more product codes.
Review panels
- Hematology (12)
- Clinical Chemistry (7)
- Microbiology (2)
- Clinical Toxicology (2)
- Immunology (1)
Most recent Ortho Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K802404 | ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE | DCF | 1980-10-23 | 17 |
| K801507 | ANTIGEN CONTROL CELLS | GOL | 1980-08-20 | 51 |
| K800357 | BI-LEVEL ASSAYED CARD. DRUG CONT., I,II | LAS | 1980-04-16 | 56 |
| K800310 | ORTHO ANTISERA CONTROL | KSF | 1980-03-05 | 22 |
| K791791 | ORTHO ANTIBODY ENHANCEMENT SOLUTION | KSG | 1979-10-11 | 30 |
| K791301 | ORTHO TSH RIA KIT | JLW | 1979-09-24 | 70 |
| K790813 | MULTECON BLOOD GAS CONTROL | JJS | 1979-06-28 | 62 |
| K782166 | SLIDE TEST FOR PREGNANCY, GRAVINDEX 90 | JHJ | 1979-04-04 | 96 |
| K782063 | PREGNANCY, SENSIDEX TUBE TEST | JHJ | 1979-04-04 | 114 |
| K781638 | RUBINDEX*DIRECT SYSTEM | GOK | 1978-12-20 | 90 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ortho 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Ortho Diagnostics, Inc. (a text match, not an official crosswalk):
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.
- Ortho Diagnostic Systems, Inc. (126 510(k)s)
- Ortho Development Corp. (64 510(k)s)
- Ortho Tec, LLC (22 510(k)s)
- Ortho Clinical Diagnostics (16 510(k)s)
- Ortho Pharmaceutical Corp. (9 510(k)s)
- Ortho Source (9 510(k)s)
- Ortho Organizers, Inc. (8 510(k)s)
- Ortho Kinetics Corp. (7 510(k)s)
- Ortho Instruments (6 510(k)s)
- Ortho Kinematics, Inc. (6 510(k)s)
- Ortho Solutions Limited (6 510(k)s)
- Ortho Pared Instruments, Inc. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ortho Diagnostics, Inc.?
FDA lists 24 510(k) clearances under the applicant name “Ortho Diagnostics, Inc.” (first 1977, latest 1980), across 18 product codes in 5 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 Ortho Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ortho Diagnostics, Inc. is 36 days.
Which FDA product codes appear under Ortho Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are JBQ (Antithrombin Iii Quantitation, 2); JHJ (Agglutination Method, Human Chorionic Gonadotropin, 2); JPK (Mixture, Hematology Quality Control, 2).
Next steps
- See all 24 Ortho Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JBQ, Ortho 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.