The following data is part of a premarket notification filed by Stanbio Laboratory with the FDA for Stanbio Y-gt (liquicolor) Test Set.
| Device ID | K941315 |
| 510k Number | K941315 |
| Device Name: | STANBIO Y-GT (LIQUICOLOR) TEST SET |
| Classification | Kinetic Method, Gamma-glutamyl Transpeptidase |
| 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 | JQB |
| CFR Regulation Number | 862.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-18 |
| Decision Date | 1994-07-14 |