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 |