The following data is part of a premarket notification filed by Gamma Enterprises, Inc. with the FDA for Creatine Phosphokinase (cpk).
| Device ID | K780504 |
| 510k Number | K780504 |
| Device Name: | CREATINE PHOSPHOKINASE (CPK) |
| Classification | Differential Rate Kinetic Method, Cpk Or Isoenzymes |
| Applicant | GAMMA ENTERPRISES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JHS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-03-30 |
| Decision Date | 1978-05-03 |