The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Boehringer Mannheim Ethyl Alcohol Assay.
| Device ID | K952839 |
| 510k Number | K952839 |
| Device Name: | BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY |
| Classification | Nad-nadh, Specific Reagent For Alcohol Enzyme Method |
| Applicant | BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Contact | John D Stevens |
| Correspondent | John D Stevens BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Product Code | DML |
| CFR Regulation Number | 862.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-21 |
| Decision Date | 1995-08-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04015630991778 | K952839 | 000 |
| 04015630991761 | K952839 | 000 |