The following data is part of a premarket notification filed by Simmler, Inc. with the FDA for Multichem(r) Y -glutamyltransferase (y -gt).
| Device ID | K874903 |
| 510k Number | K874903 |
| Device Name: | MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT) |
| Classification | Colorimetric Method, Gamma-glutamyl Transpeptidase |
| Applicant | SIMMLER, INC. POST OFFICE BOX 25179 St. Louis, MO 63125 |
| Contact | Quincy E Crider |
| Correspondent | Quincy E Crider SIMMLER, INC. POST OFFICE BOX 25179 St. Louis, MO 63125 |
| Product Code | JPZ |
| CFR Regulation Number | 862.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-01 |
| Decision Date | 1988-02-11 |