The following data is part of a premarket notification filed by American Monitor Corp. with the FDA for Gamma-glutamyltransferase.
| Device ID | K890312 |
| 510k Number | K890312 |
| Device Name: | GAMMA-GLUTAMYLTRANSFERASE |
| Classification | Kinetic Method, Gamma-glutamyl Transpeptidase |
| Applicant | AMERICAN MONITOR CORP. P.O. BOX 68505 Indianapolis, IN 46268 |
| Contact | Marcia J Arentz |
| Correspondent | Marcia J Arentz AMERICAN MONITOR CORP. P.O. BOX 68505 Indianapolis, IN 46268 |
| Product Code | JQB |
| CFR Regulation Number | 862.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-23 |
| Decision Date | 1989-03-24 |