The following data is part of a premarket notification filed by American Monitor Corp. with the FDA for Durazyme Got/ast.
| Device ID | K800116 |
| 510k Number | K800116 |
| Device Name: | DURAZYME GOT/AST |
| Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
| Applicant | AMERICAN MONITOR CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CIT |
| CFR Regulation Number | 862.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-01-18 |
| Decision Date | 1980-02-13 |