The following data is part of a premarket notification filed by Olympus Diagnostica Gmbh with the FDA for Olympus Creatine Kinase Reagent Osr6179/6279.
| Device ID | K994189 |
| 510k Number | K994189 |
| Device Name: | OLYMPUS CREATINE KINASE REAGENT OSR6179/6279 |
| Classification | Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| Applicant | OLYMPUS DIAGNOSTICA GMBH TWO CORPORATE CENTER DR. Melville, NY 11747 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler OLYMPUS DIAGNOSTICA GMBH TWO CORPORATE CENTER DR. Melville, NY 11747 |
| Product Code | CGS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-13 |
| Decision Date | 2000-01-20 |