The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Ast.
| Device ID | K983131 |
| 510k Number | K983131 |
| Device Name: | AST |
| Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
| Applicant | ABBOTT LABORATORIES 1920 HURD DR. Irving, TX 75038 |
| Contact | Linda Morris |
| Correspondent | Linda Morris ABBOTT LABORATORIES 1920 HURD DR. Irving, TX 75038 |
| Product Code | CIT |
| CFR Regulation Number | 862.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-08 |
| Decision Date | 1998-09-28 |
| Summary: | summary |