The following data is part of a premarket notification filed by Princeton Biomedix with the FDA for Assay For Gamma Glutamyltransferase.
| Device ID | K760346 |
| 510k Number | K760346 |
| Device Name: | ASSAY FOR GAMMA GLUTAMYLTRANSFERASE |
| Classification | Colorimetric Method, Gamma-glutamyl Transpeptidase |
| Applicant | PRINCETON BIOMEDIX 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JPZ |
| CFR Regulation Number | 862.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-08-02 |
| Decision Date | 1976-10-27 |