The following data is part of a premarket notification filed by Tech-neal Scientific, Inc. with the FDA for Gamma Glutamyl Transferase Reagent Set.
| Device ID | K881239 |
| 510k Number | K881239 |
| Device Name: | GAMMA GLUTAMYL TRANSFERASE REAGENT SET |
| Classification | Colorimetric Method, Gamma-glutamyl Transpeptidase |
| Applicant | TECH-NEAL SCIENTIFIC, INC. 5410 S. KILPATRICK AVE. Chicago, IL 60632 |
| Contact | Arun Sanghavi |
| Correspondent | Arun Sanghavi TECH-NEAL SCIENTIFIC, INC. 5410 S. KILPATRICK AVE. Chicago, IL 60632 |
| Product Code | JPZ |
| CFR Regulation Number | 862.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-22 |
| Decision Date | 1988-05-31 |