Panels › Clinical Toxicology › Product code DML · Class 2
Nad-Nadh, Specific Reagent For Alcohol Enzyme Method
Regulation 862.3040
0510(k)s in 12 months (13 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in DML
| Company | 510(k)s | Recalls |
|---|---|---|
| Syva Co. | 3 | 0 |
| Abbott Laboratories | 2 | 0 |
| American Dade | 1 | 0 |
| American Monitor Corp. | 1 | 0 |
| Ansys, Inc. | 1 | 0 |
| Boehringer Mannheim Corp. | 1 | 0 |
| Em Diagnostic Systems, Inc. | 1 | 0 |
| Reagents Applications, Inc. | 1 | 0 |
| Sigma Diagnostics, Inc. | 1 | 0 |
| Toxi-Lab, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 14, 2001 | K013538 | ETHANOL Abbott Laboratories | DML |
| Feb 1, 2000 | K993980 | SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL Syva Co. | DML |
| Sep 19, 1996 | K963197 | ON.SITE ALCOHOL Ansys, Inc. | DML |
| Sep 27, 1995 | K953765 | AXSYM REA ETHANOL Abbott Laboratories | DML |
| Aug 24, 1995 | K952839 | BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY Boehringer Mannheim Corp. | DML |
| Jan 12, 1993 | K923337 | ON*SITE ALCOHOL Toxi-Lab, Inc. | DML |
| Dec 27, 1991 | K914777 | SIGMA PROCEDURE NO. 333-UV Sigma Diagnostics, Inc. | DML |
| Jan 11, 1988 | K874382 | RAICHEM(TM) ALCOHOL REAGENT Reagents Applications, Inc. | DML |
| Jul 7, 1987 | K872180 | KINETIC 610 ETHANOL American Monitor Corp. | DML |
| Sep 29, 1986 | K863419 | EMDS(TM) ALCOHOL TESTPACKS, #67691/95 Em Diagnostic Systems, Inc. | DML |
| Apr 13, 1984 | K840769 | PARAMAX ALCOHOL REAGENT American Dade | DML |
| Mar 23, 1984 | K840400 | EMIT ST SERUM ETHYL ALCOHOL ASSAY Syva Co. | DML |
| Mar 19, 1984 | K840171 | EMIT ST URINE ETHYL ALCOHOL ASSAY Syva Co. | DML |
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