Clinical Controls, Inc.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Clinical Controls, Inc.” (first 1994, latest 2001), across 8 product codes in 4 review panels. Median 510(k) review time under this name: 57 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 4 | 4 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 4 | 4 |
| GIL | Plasma, Fibrinogen Control | 3 | 3 |
| JJT | Enzyme Controls (Assayed And Unassayed) | 3 | 3 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 1 | 1 |
| DGD | Igg, Ferritin, Antigen, Antiserum, Control | 1 | 1 |
| DIF | Drug Mixture Control Materials | 1 | 1 |
| JZG | System, Test, Beta-2-Microglobulin Immunological | 1 | 1 |
Review panels
- Clinical Chemistry (11)
- Hematology (3)
- Immunology (3)
- Clinical Toxicology (1)
Most recent Clinical Controls, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K012907 | LIQUISPX LIQUID SALIVA OR UNRINE DRUG OF ABUSE CONTROL | DIF | 2001-09-28 | 30 |
| K964278 | WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6 | JJX | 1996-11-22 | 25 |
| K962432 | LIQUISPEX URINE (MICRO)ALBUMIN CONTROL | JJX | 1996-07-05 | 11 |
| K955691 | SERUM VOLATILES CONTROL LEVEL 1 & 2 | JJY | 1996-04-24 | 132 |
| K955690 | AQUEOUS ETHANOL/AMMONIA CONTROL LEVEL 1, 2, & 3 | JJY | 1996-04-24 | 132 |
| K946265 | FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3 | GIL | 1995-08-24 | 244 |
| K935598 | PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2 | GIL | 1995-05-02 | 529 |
| K946266 | FERRITIN CONTROL - LEVEL 1, 2, 3 | DGD | 1995-02-10 | 49 |
| K946050 | LIQUISPEX(TM) LIQUID CRP CONTROL LEVEL 1 AND 2 | DCK | 1995-02-10 | 60 |
| K946049 | LIQUISPEX(TM) LIQUID B2M/CRP CONTROL LEVEL 1 AND 2 | JJY | 1995-02-10 | 60 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Clinical Controls, 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.
- Clinical Data, Inc. (37 510(k)s)
- Clinical Sciences, Inc. (30 510(k)s)
- Clinical Assays, Inc. (27 510(k)s)
- Clinical Innovations, LLC (18 510(k)s)
- Clinical Resources, Inc. (14 510(k)s)
- Clinical Technology Corp. (12 510(k)s)
- Clinical Connections, Inc. (10 510(k)s)
- Clinical Diagnostics, Inc. (8 510(k)s)
- Clinical Convenience Products, Inc. (6 510(k)s)
- Clinical Laserthermia Systems, AB (6 510(k)s)
- Clinical Neuro Systems, LLC (5 510(k)s)
- Clinical Bioresearch (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Clinical Controls, Inc.?
FDA lists 18 510(k) clearances under the applicant name “Clinical Controls, Inc.” (first 1994, latest 2001), across 8 product codes in 4 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 Clinical Controls, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Clinical Controls, Inc. is 57 days.
Which FDA product codes appear under Clinical Controls, Inc.?
The most frequent FDA product codes under this applicant name are JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 4); JJY (Multi-Analyte Controls, All Kinds (Assayed), 4); GIL (Plasma, Fibrinogen Control, 3).
Next steps
- See all 18 Clinical Controls, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJX, Clinical Controls, 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.