Company ยท US
Baker Instructions Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 1988. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GKL | Counter, Cell, Automated (Particle Counter) | 2 |
| JJG | Analyzer, Chemistry, Centrifugal, For Clinical Use | 2 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 |
| GKZ | Counter, Differential Cell | 1 |
| JCN | Control, Cell Counter, Normal And Abnormal | 1 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 |
| KLS | Enzyme Immunoassay, Theophylline | 1 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 7, 1988 | K882612 | SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTER Baker Instructions Corp. | GKZ |
| Oct 20, 1987 | K873596 | BAKER TDM THEOPHYLLINE ASSAY Baker Instructions Corp. | KLS |
| Mar 31, 1987 | K870603 | SYSTEM 9000 AUTOMATED CELL COUNTER Baker Instructions Corp. | GKL |
| Nov 4, 1985 | K854173 | UCD URINE SPECIMEN COLLECTOR Baker Instructions Corp. | KNX |
| May 2, 1985 | K850386 | SYSTEM 8000 CELL COUNTER Baker Instructions Corp. | GKL |
| Nov 7, 1983 | K833116 | SPIRIT CHEMISTRY SYSTEM Baker Instructions Corp. | JJE |
| Oct 4, 1983 | K832716 | ENCORE CHEMISTRY ANALYZER Baker Instructions Corp. | JJG |
| Apr 5, 1983 | K830641 | ENCORE CHEMISTRY ANALYZER Baker Instructions Corp. | JJG |
| Jul 30, 1982 | K821956 | HAEM-C PLUS BLOOD REFERENCE CONTROLS Baker Instructions Corp. | JCN |
| Jul 1, 1981 | K811694 | CENTRIFICHEM ALT/AGPT OPTIMIZED REAGENT Baker Instructions Corp. | CKA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||