The following data is part of a premarket notification filed by Abaxis, Inc. with the FDA for Gamma Glutamyl Transferase Test System.
| Device ID | K955770 |
| 510k Number | K955770 |
| Device Name: | GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM |
| Classification | Kinetic Method, Gamma-glutamyl Transpeptidase |
| Applicant | ABAXIS, INC. 1320 CHESAPEAKE TERRACE Sunnyvale, CA 94089 |
| Contact | Daniel Wong |
| Correspondent | Daniel Wong ABAXIS, INC. 1320 CHESAPEAKE TERRACE Sunnyvale, CA 94089 |
| Product Code | JQB |
| CFR Regulation Number | 862.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-21 |
| Decision Date | 1996-09-09 |