The following data is part of a premarket notification filed by Sterling Diagnostics, Inc. with the FDA for Gamma Glutamyl Transpeptidase (ggtp) Reagent Set.
| Device ID | K860348 |
| 510k Number | K860348 |
| Device Name: | GAMMA GLUTAMYL TRANSPEPTIDASE (GGTP) REAGENT SET |
| Classification | Colorimetric Method, Gamma-glutamyl Transpeptidase |
| Applicant | STERLING DIAGNOSTICS, INC. 34210 DEQUINDRE RD. Sterling Heights, MI 48077 |
| Contact | David L Callender |
| Correspondent | David L Callender STERLING DIAGNOSTICS, INC. 34210 DEQUINDRE RD. Sterling Heights, MI 48077 |
| Product Code | JPZ |
| CFR Regulation Number | 862.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-30 |
| Decision Date | 1986-03-17 |