The following data is part of a premarket notification filed by Amresco, Inc. with the FDA for Creatine Phosphokinase.
| Device ID | K903775 |
| 510k Number | K903775 |
| Device Name: | CREATINE PHOSPHOKINASE |
| Classification | Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| Applicant | AMRESCO, INC. 30175 SOLON INDUSTRIAL PKWY. Solon, OH 44139 |
| Contact | Praful Patel |
| Correspondent | Praful Patel AMRESCO, INC. 30175 SOLON INDUSTRIAL PKWY. Solon, OH 44139 |
| Product Code | CGS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-20 |
| Decision Date | 1990-10-04 |