The following data is part of a premarket notification filed by Stanbio Laboratory with the FDA for Stanbio Alt/gpt (luqui-uv) Test Set.
| Device ID | K941314 |
| 510k Number | K941314 |
| Device Name: | STANBIO ALT/GPT (LUQUI-UV) TEST SET |
| Classification | Nadh Oxidation/nad Reduction, Alt/sgpt |
| Applicant | STANBIO LABORATORY 2930 EAST HOUSTON ST. San Antonio, TX 78202 |
| Contact | Albert Blanco |
| Correspondent | Albert Blanco STANBIO LABORATORY 2930 EAST HOUSTON ST. San Antonio, TX 78202 |
| Product Code | CKA |
| CFR Regulation Number | 862.1030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-18 |
| Decision Date | 1994-07-20 |