The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Aspartate Aminotransferase Procedure No.. 58-uv.
| Device ID | K954839 |
| 510k Number | K954839 |
| Device Name: | ASPARTATE AMINOTRANSFERASE PROCEDURE NO.. 58-UV |
| Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
| Applicant | SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103 |
| Contact | William R Gilbert |
| Correspondent | William R Gilbert SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103 |
| Product Code | CIT |
| CFR Regulation Number | 862.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-20 |
| Decision Date | 1996-01-05 |