Catachem, Inc.: FDA filings under this applicant name
FDA lists 41 510(k) clearances under the applicant name “Catachem, Inc.” (first 1985, latest 2007), across 32 product codes in 3 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 |
|---|---|---|---|
| CIG | Diazo Colorimetry, Bilirubin | 4 | 4 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 2 | 2 |
| CHJ | Mercuric Thiocyanate, Colorimetry, Chloride | 2 | 2 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 2 | 2 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 2 | 2 |
| JIY | Photometric Method, Iron (Non-Heme) | 2 | 2 |
| KNK | Acid, Uric, Uricase (Colorimetric) | 2 | 2 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 | 1 |
| CDW | Diacetyl-Monoxime, Urea Nitrogen | 1 | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 | 1 |
Plus 22 more product codes.
Review panels
- Clinical Chemistry (39)
- Hematology (1)
- Immunology (1)
Most recent Catachem, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K062503 | CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT | KWW | 2007-01-19 | 147 |
| K945408 | 340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER | CHJ | 1995-02-22 | 111 |
| K932871 | UIBC FOR DISCREET RANDOM ACCESS ANALYZER | CFM | 1993-09-08 | 86 |
| K903341 | MAGNESIUM | JGJ | 1990-08-22 | 28 |
| K902326 | AMYLASE FOR MANUAL/AUTOMATED APPLICATIONS | JFJ | 1990-07-31 | 68 |
| K902877 | TOTAL IRON FOR MANUAL/AUTOMATED | JIY | 1990-07-27 | 25 |
| K895748 | BICARBONATE FOR MANUAL/AUTOMATED APPLICATIONS | KHS | 1989-12-21 | 86 |
| K895821 | URIC ACID FOR MANUAL/AUTOMATED APPLICATIONS | KNK | 1989-12-05 | 67 |
| K894715 | CREATINE KINASE FOR MANUAL/AUTOMATED APPLICATIONS | CGS | 1989-11-08 | 106 |
| K894476 | CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION | CJY | 1989-10-12 | 86 |
31 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Catachem, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Catachem, Inc.?
FDA lists 41 510(k) clearances under the applicant name “Catachem, Inc.” (first 1985, latest 2007), across 32 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 Catachem, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Catachem, Inc. is 57 days.
Which FDA product codes appear under Catachem, Inc.?
The most frequent FDA product codes under this applicant name are CIG (Diazo Colorimetry, Bilirubin, 4); CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, 2); CHJ (Mercuric Thiocyanate, Colorimetry, Chloride, 2).
Next steps
- See all 41 Catachem, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CIG, Catachem, 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.