The following data is part of a premarket notification filed by Amresco, Inc. with the FDA for Ggt Reagent.
| Device ID | K905618 |
| 510k Number | K905618 |
| Device Name: | GGT REAGENT |
| Classification | Colorimetric Method, Gamma-glutamyl Transpeptidase |
| Applicant | AMRESCO, INC. 30175 SOLON INDUSTRIAL PKWY. Solon, OH 44139 |
| Contact | Leonard Szymkowski |
| Correspondent | Leonard Szymkowski AMRESCO, INC. 30175 SOLON INDUSTRIAL PKWY. Solon, OH 44139 |
| Product Code | JPZ |
| CFR Regulation Number | 862.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-14 |
| Decision Date | 1991-02-26 |