The following data is part of a premarket notification filed by Tech-co, Inc. with the FDA for Gamma-glutamyl Transferase.
| Device ID | K881626 |
| 510k Number | K881626 |
| Device Name: | GAMMA-GLUTAMYL TRANSFERASE |
| Classification | Kinetic Method, Gamma-glutamyl Transpeptidase |
| Applicant | TECH-CO, INC. 24111 BEVERLY Oak Park, MI 48237 |
| Contact | Chen, Phd |
| Correspondent | Chen, Phd TECH-CO, INC. 24111 BEVERLY Oak Park, MI 48237 |
| Product Code | JQB |
| CFR Regulation Number | 862.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-12 |
| Decision Date | 1988-05-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10673486001846 | K881626 | 000 |
| 10673486001839 | K881626 | 000 |