ROCHE COBAS IBTEGRA REAGENT CASSETTES
FDA 510(k) clearance K964457 · decided 1997-01-13
Clearance details
- K-number
- K964457
- Device name
- ROCHE COBAS IBTEGRA REAGENT CASSETTES
- Applicant
- Roche Diagnostic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-11-06
- Decision date
- 1997-01-13
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- JQB
- Device class
- 1
- Regulation number
- 862.1360
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Branchburg, NJ, US
- Third-party review
- No
- Expedited review
- No
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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 |
| 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 |
| STANBIO Y-GT (LIQUICOLOR) TEST SET (K941315) | Stanbio Laboratory | 1994-07-14 |
| 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
| Record | Firm | Date |
|---|---|---|
| Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***added as of 5/10/19* recall (Z-1146-2019) | Roche Diagnostics Corporation | 2019-04-13 |
| Lactate. Intended for use on COBAS INTEGRA 800 and 400 plus systems, cobas c111, Roche/Hit recall (Z-1926-2015) | Roche Diagnostics Operations, Inc. | 2015-06-27 |