The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Unifast Gamma-gt.
| Device ID | K873135 |
| 510k Number | K873135 |
| Device Name: | UNIFAST GAMMA-GT |
| Classification | Kinetic Method, Gamma-glutamyl Transpeptidase |
| Applicant | SCLAVO, INC. 5 MANSARD COURT Wayne, NJ 07470 |
| Contact | Debra Hofmeister |
| Correspondent | Debra Hofmeister SCLAVO, INC. 5 MANSARD COURT Wayne, NJ 07470 |
| Product Code | JQB |
| CFR Regulation Number | 862.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-10 |
| Decision Date | 1987-09-04 |