Careside, Inc.: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Careside, Inc.” (first 1998, latest 2002), across 20 product codes in 3 review panels. Median 510(k) review time under this name: 64 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 |
|---|---|---|---|
| CIG | Diazo Colorimetry, Bilirubin | 2 | 2 |
| JHS | Differential Rate Kinetic Method, Cpk Or Isoenzymes | 2 | 2 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 | 1 |
| CFH | Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase | 1 | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 | 1 |
| CJY | Azo Dye, Calcium | 1 | 1 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 | 1 |
| DIH | Colorimetry, Cholinesterase | 1 | 1 |
Plus 10 more product codes.
Review panels
- Clinical Chemistry (19)
- Hematology (2)
- Clinical Toxicology (1)
Most recent Careside, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K020484 | CARESIDE LDH | CFH | 2002-07-03 | 140 |
| K020486 | CARESIDE GGT | JPZ | 2002-07-01 | 138 |
| K020487 | CARESIDE ALT | CKA | 2002-06-04 | 111 |
| K020488 | CARESIDE TRGLYCERIDE | CDT | 2002-04-15 | 61 |
| K002792 | CARESIDE CHOLINESTERASE | DIH | 2000-11-08 | 62 |
| K001462 | CARESIDE HEMOGLOBIN | KHG | 2000-08-21 | 103 |
| K993771 | CARESIDE DIRECT BILIRUBIN | CIG | 1999-12-27 | 49 |
| K993634 | CARESIDE ANALYZER | JJF | 1999-12-02 | 36 |
| K992475 | CARESIDE CO2, TOTAL | KHS | 1999-09-15 | 51 |
| K991717 | CARESIDE MG | JGJ | 1999-08-10 | 82 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Careside, 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.
- Careside Hemotology, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Careside, Inc.?
FDA lists 22 510(k) clearances under the applicant name “Careside, Inc.” (first 1998, latest 2002), across 20 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 Careside, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Careside, Inc. is 64 days.
Which FDA product codes appear under Careside, Inc.?
The most frequent FDA product codes under this applicant name are CIG (Diazo Colorimetry, Bilirubin, 2); JHS (Differential Rate Kinetic Method, Cpk Or Isoenzymes, 2); CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, 1).
Next steps
- See all 22 Careside, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CIG, Careside, 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.