Baker Instructions Corp.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Baker Instructions Corp.” (first 1981, latest 1988), across 8 product codes in 4 review panels. Median 510(k) review time under this name: 47 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 |
|---|---|---|---|
| GKL | Counter, Cell, Automated (Particle Counter) | 2 | 2 |
| JJG | Analyzer, Chemistry, Centrifugal, For Clinical Use | 2 | 2 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 | 1 |
| GKZ | Counter, Differential Cell | 1 | 1 |
| JCN | Control, Cell Counter, Normal And Abnormal | 1 | 1 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | 1 |
| KLS | Enzyme Immunoassay, Theophylline | 1 | 1 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 1 | 1 |
Review panels
Most recent Baker Instructions Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K882612 | SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTER | GKZ | 1988-09-07 | 75 |
| K873596 | BAKER TDM THEOPHYLLINE ASSAY | KLS | 1987-10-20 | 46 |
| K870603 | SYSTEM 9000 AUTOMATED CELL COUNTER | GKL | 1987-03-31 | 48 |
| K854173 | UCD URINE SPECIMEN COLLECTOR | KNX | 1985-11-04 | 20 |
| K850386 | SYSTEM 8000 CELL COUNTER | GKL | 1985-05-02 | 90 |
| K833116 | SPIRIT CHEMISTRY SYSTEM | JJE | 1983-11-07 | 55 |
| K832716 | ENCORE CHEMISTRY ANALYZER | JJG | 1983-10-04 | 53 |
| K830641 | ENCORE CHEMISTRY ANALYZER | JJG | 1983-04-05 | 35 |
| K821956 | HAEM-C PLUS BLOOD REFERENCE CONTROLS | JCN | 1982-07-30 | 30 |
| K811694 | CENTRIFICHEM ALT/AGPT OPTIMIZED REAGENT | CKA | 1981-07-01 | 16 |
Recalls
openFDA lists no recalls under a recalling firm named Baker Instructions Corp..
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.
- Baker Diagnostics (1 510(k)s)
- Baker & Hostetler (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Baker Instructions Corp.?
FDA lists 10 510(k) clearances under the applicant name “Baker Instructions Corp.” (first 1981, latest 1988), across 8 product codes in 4 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 Baker Instructions Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Baker Instructions Corp. is 47 days.
Which FDA product codes appear under Baker Instructions Corp.?
The most frequent FDA product codes under this applicant name are GKL (Counter, Cell, Automated (Particle Counter), 2); JJG (Analyzer, Chemistry, Centrifugal, For Clinical Use, 2); CKA (Nadh Oxidation/Nad Reduction, Alt/Sgpt, 1).
Next steps
- See all 10 Baker Instructions Corp. clearances with predicates and recalls
- Run predicate analysis for product code GKL, Baker Instructions Corp.'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.