The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Axsm Procainamide Assay.
| Device ID | K955444 |
| 510k Number | K955444 |
| Device Name: | ABBOTT AXSM PROCAINAMIDE ASSAY |
| Classification | Enzyme Immunoassay, Procainamide |
| Applicant | ABBOTT LABORATORIES DEPT: 09V8 BLDG: AP5-2 100 ABBOTT PARK ROAD Abbott Park, IL 60064 -3500 |
| Contact | Grace Lemieux |
| Correspondent | Grace Lemieux ABBOTT LABORATORIES DEPT: 09V8 BLDG: AP5-2 100 ABBOTT PARK ROAD Abbott Park, IL 60064 -3500 |
| Product Code | LAR |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-28 |
| Decision Date | 1996-04-02 |
| Summary: | summary |