Clinical Data, Inc.: FDA filings under this applicant name
FDA lists 37 510(k) clearances under 2 spellings of the applicant name “Clinical Data, Inc.” (first 1982, latest 2007), across 30 product codes in 6 review panels. Median 510(k) review time under this name: 41 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 |
|---|---|---|---|
| DRX | Electrode, Electrocardiograph | 3 | 3 |
| KNK | Acid, Uric, Uricase (Colorimetric) | 3 | 3 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 2 | 2 |
| CIG | Diazo Colorimetry, Bilirubin | 2 | 2 |
| JIY | Photometric Method, Iron (Non-Heme) | 2 | 2 |
| BZQ | Monitor, Breathing Frequency | 1 | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 | 1 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | 1 |
Plus 20 more product codes.
Review panels
- Clinical Chemistry (21)
- Clinical Toxicology (7)
- Cardiovascular (5)
- Anesthesiology (2)
- Hematology (1)
- Immunology (1)
Most recent Clinical Data, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K071706 | ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118) | LBS | 2007-12-20 | 182 |
| K052591 | NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT | DCK | 2006-02-09 | 141 |
| K033983 | VITALAB IRON REAGENT | JIY | 2004-05-21 | 150 |
| K040631 | VITALAB DIRECT BILIRUBIN REAGENT | CIG | 2004-03-18 | 8 |
| K040534 | VITALAB AMYLASE REAGENT | JFJ | 2004-03-11 | 9 |
| K034000 | VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR | CDT | 2004-03-10 | 77 |
| K040508 | VITALAB MAGNESIUM REAGENT | JGJ | 2004-03-08 | 10 |
| K040467 | VITALAB URIC ACID REAGENT | KNK | 2004-03-08 | 13 |
| K031042 | ATAC HEMOGLOBIN A1C REAGENT KIT | LCP | 2003-11-03 | 216 |
| K031044 | ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR | KNK | 2003-07-15 | 105 |
27 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Clinical Data, 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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Clinical Data, Inc. (36)
- Clinical Data (1)
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 Sciences, Inc. (30 510(k)s)
- Clinical Assays, Inc. (27 510(k)s)
- Clinical Controls, Inc. (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 Innovations, Inc. (9 510(k)s)
- Clinical Innovations, LLC (9 510(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)
Frequently asked questions
How many FDA 510(k) clearances are listed under Clinical Data, Inc.?
FDA lists 37 510(k) clearances under 2 spellings of the applicant name “Clinical Data, Inc.” (first 1982, latest 2007), across 30 product codes in 6 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 Data, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Clinical Data, Inc. is 41 days.
Which FDA product codes appear under Clinical Data, Inc.?
The most frequent FDA product codes under this applicant name are DRX (Electrode, Electrocardiograph, 3); KNK (Acid, Uric, Uricase (Colorimetric), 3); CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, 2).
Next steps
- See all 37 Clinical Data, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DRX, Clinical Data, 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.