The following data is part of a premarket notification filed by Fisher Scientific Co., Llc. with the FDA for Serum, Creatinine Phosphokinase.
| Device ID | K790015 |
| 510k Number | K790015 |
| Device Name: | SERUM, CREATININE PHOSPHOKINASE |
| Classification | Differential Rate Kinetic Method, Cpk Or Isoenzymes |
| Applicant | FISHER SCIENTIFIC CO., LLC. 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 | 1979-01-03 |
| Decision Date | 1979-02-15 |