Panels › Clinical Toxicology › Product code DNN · Class 2
Calibrators, Ethyl Alcohol
Regulation 862.3200
0510(k)s in 12 months (7 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in DNN
| Company | 510(k)s | Recalls |
|---|---|---|
| Emd Chemicals, Inc. | 2 | 1 |
| Syva Co. | 2 | 0 |
| Diagnostic Reagents, Inc. | 1 | 0 |
| Diagnostic Systems | 1 | 0 |
| Hospira, Inc. | 0 | 1 |
| Verichem Laboratories, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 31, 1999 | K990516 | ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS Emd Chemicals, Inc. | DNN |
| Oct 1, 1997 | K973054 | ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS Emd Chemicals, Inc. | DNN |
| Dec 9, 1992 | K924733 | ETHYL ALCOHOL CALIBRATORS & CONTROL Diagnostic Reagents, Inc. | DNN |
| Aug 4, 1988 | K882117 | ETHYL ALCOHOL STANDARD Verichem Laboratories, Inc. | DNN |
| Sep 16, 1985 | K853532 | ALCOHOL CALIBRATORS Diagnostic Systems | DNN |
| Mar 6, 1981 | K810466 | ETHYL ALCOHOL SERUM CALIBRATOR Syva Co. | DNN |
| Oct 31, 1980 | K802620 | EMIT-STM ETHYL ALCOHOL URINE CALIBRATOR Syva Co. | DNN |
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