The following data is part of a premarket notification filed by Macomb Chemical Co. with the FDA for Creatine Phosphokinase (cpk) Reagent Set.
| Device ID | K792533 |
| 510k Number | K792533 |
| Device Name: | CREATINE PHOSPHOKINASE (CPK) REAGENT SET |
| Classification | U.v. Method, Cpk Isoenzymes |
| Applicant | MACOMB CHEMICAL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JHW |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-12-07 |
| Decision Date | 1980-01-11 |