The following data is part of a premarket notification filed by Amresco, Inc. with the FDA for Ggt Reagents, 7738, 7739, 7538, 7438 & 7138.
| Device ID | K905096 |
| 510k Number | K905096 |
| Device Name: | GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138 |
| Classification | Kinetic Method, Gamma-glutamyl Transpeptidase |
| Applicant | AMRESCO, INC. 30175 SOLON INDUSTRIAL PKWY. Solon, OH 44139 |
| Contact | Praful R Patel |
| Correspondent | Praful R Patel AMRESCO, INC. 30175 SOLON INDUSTRIAL PKWY. Solon, OH 44139 |
| Product Code | JQB |
| CFR Regulation Number | 862.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-13 |
| Decision Date | 1990-11-28 |