The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Creatine Kinase Reagent Osr6179/osr6279.
| Device ID | K043202 |
| 510k Number | K043202 |
| Device Name: | OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279 |
| Classification | Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| Applicant | OLYMPUS AMERICA, INC. 3131 WEST ROYAL LN. Irving, TX 75063 -3104 |
| Contact | Bev Harding |
| Correspondent | Bev Harding OLYMPUS AMERICA, INC. 3131 WEST ROYAL LN. Irving, TX 75063 -3104 |
| Product Code | CGS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-18 |
| Decision Date | 2004-12-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590020262 | K043202 | 000 |
| 15099590010744 | K043202 | 000 |