The following data is part of a premarket notification filed by Derma Media Lab., Inc. with the FDA for Gamma-glutamyl Transpeptidase.
| Device ID | K964916 |
| 510k Number | K964916 |
| Device Name: | GAMMA-GLUTAMYL TRANSPEPTIDASE |
| Classification | Kinetic Method, Gamma-glutamyl Transpeptidase |
| Applicant | DERMA MEDIA LAB., INC. 8531 WELLSFORD PL., SUITE E Santa Fe Springs, CA 90670 |
| Contact | Charles C Allain, Ph.d. |
| Correspondent | Charles C Allain, Ph.d. DERMA MEDIA LAB., INC. 8531 WELLSFORD PL., SUITE E Santa Fe Springs, CA 90670 |
| Product Code | JQB |
| CFR Regulation Number | 862.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-09 |
| Decision Date | 1997-01-10 |