The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Glutamyltransferase Assay Kit.
| Device ID | K850788 |
| 510k Number | K850788 |
| Device Name: | GLUTAMYLTRANSFERASE ASSAY KIT |
| Classification | Colorimetric Method, Gamma-glutamyl Transpeptidase |
| Applicant | DIAGNOSTIC CHEMICALS, LTD. (USA) WEST ROYALTY INDUSTRIAL PARK CHARLOTTETOWN, P.E.I. Canada, CA Cle Ibo |
| Product Code | JPZ |
| CFR Regulation Number | 862.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-26 |
| Decision Date | 1985-03-19 |