The following data is part of a premarket notification filed by Emd Chemicals Inc. with the FDA for Ultrazyme Plus Gamma Gt-mca #65055-65056.
| Device ID | K830240 |
| 510k Number | K830240 |
| Device Name: | ULTRAZYME PLUS GAMMA GT-MCA #65055-65056 |
| Classification | Kinetic Method, Gamma-glutamyl Transpeptidase |
| Applicant | EMD CHEMICALS INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Contact | Alan Hershman |
| Correspondent | Alan Hershman EMD CHEMICALS INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Product Code | JQB |
| CFR Regulation Number | 862.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-25 |
| Decision Date | 1983-02-18 |