The following data is part of a premarket notification filed by American Monitor Corp. with the FDA for Aspartate Aminotranferase (ast).
| Device ID | K896000 |
| 510k Number | K896000 |
| Device Name: | ASPARTATE AMINOTRANFERASE (AST) |
| Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
| Applicant | AMERICAN MONITOR CORP. P.O. BOX 68505 Indianapolis, IN 46268 |
| Contact | Jennifer Line |
| Correspondent | Jennifer Line AMERICAN MONITOR CORP. P.O. BOX 68505 Indianapolis, IN 46268 |
| Product Code | CIT |
| CFR Regulation Number | 862.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-13 |
| Decision Date | 1990-01-11 |