The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Flow-pac Cpk Reagent Set.
| Device ID | K832977 |
| 510k Number | K832977 |
| Device Name: | FLOW-PAC CPK REAGENT SET |
| Classification | Colorimetric Method, Cpk Or Isoenzymes |
| Applicant | AMERICAN RESEARCH PRODUCTS CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JHY |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-02 |
| Decision Date | 1984-04-05 |