J.T. Baker Chemical Co.: FDA filings under this applicant name
FDA lists 54 510(k) clearances under the applicant name “J.T. Baker Chemical Co.” (first 1976, latest 1981), across 41 product codes in 5 review panels. Median 510(k) review time under this name: 36 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 |
|---|---|---|---|
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 4 | 4 |
| CIG | Diazo Colorimetry, Bilirubin | 4 | 4 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 4 | 4 |
| CGA | Glucose Oxidase, Glucose | 2 | 2 |
| GKL | Counter, Cell, Automated (Particle Counter) | 2 | 2 |
| JFS | Coulometric, Chloride | 2 | 2 |
| JQX | Nephelometer, For Clinical Use | 2 | 2 |
| CDS | Electrode, Ion Specific, Urea Nitrogen | 1 | 1 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | 1 |
| CFR | Hexokinase, Glucose | 1 | 1 |
Plus 31 more product codes.
Review panels
- Clinical Chemistry (31)
- Immunology (11)
- Hematology (7)
- Clinical Toxicology (3)
- Pathology (1)
Most recent J.T. Baker Chemical Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K803128 | SERIES 810 PLATELET ANALYZER | GKL | 1981-04-03 | 112 |
| K802080 | BAKER DIAG. ULTRARATE CHLORIDE KIT | JFS | 1980-10-10 | 43 |
| K802035 | BAKER DIAG. ULTRARATE CO2 REAGENT KIT | JFL | 1980-09-26 | 35 |
| K801909 | LSA 290 ASSAY REAGENTS/NEPHELOMETRIC | DEX | 1980-09-26 | 46 |
| K801795 | BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT. | JGS | 1980-09-16 | 49 |
| K801669 | J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO | DEM | 1980-09-16 | 56 |
| K801662 | J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH. | DEP | 1980-09-16 | 57 |
| K801661 | J.T. BAKER CERULOPLASMIN NEPHELOMETRIC | DDB | 1980-09-16 | 57 |
| K801362 | ALBUMIN NEPHELOMETRIC ASSAY | JQX | 1980-07-21 | 42 |
| K801434 | J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS | DDG | 1980-07-08 | 20 |
44 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named J.T. Baker Chemical Co..
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 J.T. Baker Chemical Co.?
FDA lists 54 510(k) clearances under the applicant name “J.T. Baker Chemical Co.” (first 1976, latest 1981), across 41 product codes in 5 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 J.T. Baker Chemical Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name J.T. Baker Chemical Co. is 36 days.
Which FDA product codes appear under J.T. Baker Chemical Co.?
The most frequent FDA product codes under this applicant name are CFJ (Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase, 4); CIG (Diazo Colorimetry, Bilirubin, 4); CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes, 4).
Next steps
- See all 54 J.T. Baker Chemical Co. clearances with predicates and recalls
- Run predicate analysis for product code CFJ, J.T. Baker Chemical Co.'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.