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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 12, 2003 | Varian, Inc. On-Site Alcohol IVD
A single use enzymatic assay for qualitative detection of alcohol in urine or saliva.
Catalog numbers:
47464 Roche Diagnostics Label
A305-02 Varian, Inc. label Terminated |
DML | None listed |
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