The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Flow-pac Ggt Reagent Set.
Device ID | K833029 |
510k Number | K833029 |
Device Name: | FLOW-PAC GGT REAGENT SET |
Classification | Kinetic Method, Gamma-glutamyl Transpeptidase |
Applicant | AMERICAN RESEARCH PRODUCTS CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | JQB |
CFR Regulation Number | 862.1360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-09-07 |
Decision Date | 1983-12-29 |