Reagents Applications, Inc.: FDA clearances and approvals
Reagents Applications, Inc. has 63 FDA 510(k) clearances (first 1980, latest 1998), across 53 product codes in 4 review panels. Median 510(k) review time: 34 days.
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 |
|---|---|---|---|
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 4 | 4 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 3 | 3 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 2 | 2 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 2 | 2 |
| JFJ | Catalytic Methods, Amylase | 2 | 2 |
| JGJ | Photometric Method, Magnesium | 2 | 2 |
| KHS | Enzymatic, Carbon-Dioxide | 2 | 2 |
| CDL | Berthelot Indophenol, Urea Nitrogen | 1 | 1 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 | 1 |
Plus 43 more product codes.
Review panels
- Clinical Chemistry (49)
- Immunology (10)
- Hematology (2)
- Clinical Toxicology (2)
Most recent Reagents Applications, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K982056 | RAICHEM CO2 REAGENT | KHS | 1998-06-24 | 15 |
| K972853 | CHOLESTEROL RAPID LIQUID REAGENT | CHH | 1997-09-24 | 89 |
| K922904 | RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND II | JJX | 1992-07-30 | 44 |
| K915191 | RAI-TROL ELEVATED LIPIDS CONTROL | JJY | 1991-12-18 | 29 |
| K913398 | RAICHEM(TM) CREATINE KINASE-MB REAGENT | CGS | 1991-09-25 | 57 |
| K911900 | RAICHEM SPIA C3 REAGENT | CZW | 1991-05-09 | 13 |
| K911899 | RAICHEM SPIA C4 REAGENT | DBI | 1991-05-09 | 13 |
| K911898 | RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT | DAD | 1991-05-08 | 12 |
| K905085 | RAICHEM GGT REAGENT | JQB | 1990-12-20 | 36 |
| K905084 | RAICHEM CREATINE KINASE REAGENT, OPTIMIZED UV | CGS | 1990-12-20 | 36 |
53 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Reagents Applications, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Reagents Applications, Inc. have?
Reagents Applications, Inc. has 63 FDA 510(k) clearances (first 1980, latest 1998), across 53 product codes in 4 review panels.
How long does FDA take to clear Reagents Applications, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Reagents Applications, Inc.'s cleared 510(k)s is 34 days.
What devices does Reagents Applications, Inc. make?
Its most frequent FDA product codes are CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, 4); CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes, 3); CEO (Phosphomolybdate (Colorimetric), Inorganic Phosphorus, 2).
Has Reagents Applications, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Reagents Applications, Inc. Related entities may recall under other names.
Next steps
- See all 63 Reagents Applications, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CDT, Reagents Applications, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.