Panels › Clinical Toxicology › Product code DID · Class 2
Bacillus Subtilis Microbiology Assay, Tobramycin
Regulation 862.3900
0510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in DID
| Company | 510(k)s | Recalls |
|---|---|---|
| Beckman Instruments, Inc. | 1 | 0 |
| Monitor Science Corp. | 1 | 0 |
| New England Nuclear | 1 | 0 |
| Nichols Institute Diagnostics | 1 | 0 |
| Syva Co. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 8, 1982 | K820773 | EMIT-ST URINE COCAINE METABOLITE ASSAY Syva Co. | DID |
| Oct 23, 1980 | K802038 | PHENYTOIN REAGENT TEST KIT Beckman Instruments, Inc. | DID |
| Aug 14, 1978 | K780950 | BIO-MONITOR TOBRAMYCIN Monitor Science Corp. | DID |
| Feb 13, 1978 | K780182 | TOBRAMYCIN 125I RIA KIT New England Nuclear | DID |
| Jan 20, 1978 | K780048 | AMINOGLYCOSIDE TEST SYSTEM Nichols Institute Diagnostics | DID |
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