The following data is part of a premarket notification filed by Biomerieux Vitek, Inc. with the FDA for Vidas Creatine Kinase Mb Assay 30-421.
| Device ID | K962549 |
| 510k Number | K962549 |
| Device Name: | VIDAS CREATINE KINASE MB ASSAY 30-421 |
| Classification | Fluorometric Method, Cpk Or Isoenzymes |
| Applicant | BIOMERIEUX VITEK, INC. 1022 HINGHAM ST. Rockland, MA 02370 |
| Contact | Terry Mcgovern |
| Correspondent | Terry Mcgovern BIOMERIEUX VITEK, INC. 1022 HINGHAM ST. Rockland, MA 02370 |
| Product Code | JHX |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-28 |
| Decision Date | 1996-08-30 |
| Summary: | summary |