K955770 is an FDA 510(k) clearance for the GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM. This device is classified as a Kinetic Method, Gamma-glutamyl Transpeptidase (Class I - General Controls, product code JQB).
Submitted by Abaxis, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on September 9, 1996, 263 days after receiving the submission on December 21, 1995.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1360.
| 510(k) Number | K955770 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 1995 |
| Decision Date | September 09, 1996 |
| Days to Decision | 263 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JQB — Kinetic Method, Gamma-glutamyl Transpeptidase |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1360 |