The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Axsym Rea Ethanol.
| Device ID | K953765 |
| 510k Number | K953765 |
| Device Name: | AXSYM REA ETHANOL |
| Classification | Nad-nadh, Specific Reagent For Alcohol Enzyme Method |
| Applicant | ABBOTT LABORATORIES DEPT: 09V8 BLDG: AP5-2 100 ABBOTT PARK ROAD Abbott Park, IL 60064 -3500 |
| Contact | Doug Kentz |
| Correspondent | Doug Kentz ABBOTT LABORATORIES DEPT: 09V8 BLDG: AP5-2 100 ABBOTT PARK ROAD Abbott Park, IL 60064 -3500 |
| Product Code | DML |
| CFR Regulation Number | 862.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-11 |
| Decision Date | 1995-09-27 |