The following data is part of a premarket notification filed by King Diagnostics, Inc. with the FDA for King Diagnostics Gamma Gt Reagent.
| Device ID | K923091 |
| 510k Number | K923091 |
| Device Name: | KING DIAGNOSTICS GAMMA GT REAGENT |
| Classification | Colorimetric Method, Gamma-glutamyl Transpeptidase |
| Applicant | KING DIAGNOSTICS, INC. 6856 HAWTHORN PARK DR. Indianapolis, IN 46220 |
| Contact | Frances Loh |
| Correspondent | Frances Loh KING DIAGNOSTICS, INC. 6856 HAWTHORN PARK DR. Indianapolis, IN 46220 |
| Product Code | JPZ |
| CFR Regulation Number | 862.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-25 |
| Decision Date | 1992-09-09 |