STANBIO Y-GT (LIQUICOLOR) TEST SET
FDA 510(k) clearance K941315 · decided 1994-07-14
Clearance details
- K-number
- K941315
- Device name
- STANBIO Y-GT (LIQUICOLOR) TEST SET
- Applicant
- Stanbio Laboratory
- Decision
- Substantially Equivalent
- Date received
- 1994-03-18
- Decision date
- 1994-07-14
- Days to decision
- 118 days
- Clearance type
- Traditional
- Product code
- JQB
- Device class
- 1
- Regulation number
- 862.1360
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- San Antonio, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30 (K974000) | Diagnostic Chemicals , Ltd. | 1997-11-04 |
| LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET (K973157) | Pointe Scientific, Inc., | 1997-10-10 |
| SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT) (K971466) | Carolina Liquid Chemistries Corp. | 1997-05-06 |
| ROCHE COBAS IBTEGRA REAGENT CASSETTES (K964457) | Roche Diagnostic Systems, Inc. | 1997-01-13 |
| GAMMA-GLUTAMYL TRANSPEPTIDASE (K964916) | Derma Media Lab., Inc. | 1997-01-10 |
| GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM (K955770) | Abaxis, Inc. | 1996-09-09 |
| Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05 (K945800) | Diagnostic Chemicals , Ltd. | 1995-06-09 |
| HICHEM Y-GT REAGENT KIT (K946192) | Hichem Diagnostics | 1995-05-02 |
| GGT QVET (K942962) | Prisma Systems | 1994-12-07 |
| GLUTAMYL-TRANSFERASE, PROCEDURE NO. 419 (K935984) | Sigma Diagnostics, Inc. | 1994-07-20 |
| GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST (K935177) | Em Diagnostic Systems, Inc. | 1993-12-16 |
| SYNERMED GGT REAGENT KIT (K931958) | Synermed, Inc. | 1993-09-08 |
Recalls involving this device
No recalls on record reference this clearance.