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 |