The following data is part of a premarket notification filed by Stanbio Laboratory with the FDA for Stanbio Ast/got (liqui-uv) Test Set, Cat No. 9020.
| Device ID | K932049 |
| 510k Number | K932049 |
| Device Name: | STANBIO AST/GOT (LIQUI-UV) TEST SET, CAT NO. 9020 |
| Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
| Applicant | STANBIO LABORATORY 2930 EAST HOUSTON ST. San Antonio, TX 78202 |
| Contact | Judith A Harbour |
| Correspondent | Judith A Harbour STANBIO LABORATORY 2930 EAST HOUSTON ST. San Antonio, TX 78202 |
| Product Code | CIT |
| CFR Regulation Number | 862.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-27 |
| Decision Date | 1993-11-16 |