VIDAS T UPTAKE
FDA 510(k) clearance K935816 · decided 1994-03-22
Clearance details
- K-number
- K935816
- Device name
- VIDAS T UPTAKE
- Applicant
- Biomerieux Vitek, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-12-02
- Decision date
- 1994-03-22
- Days to decision
- 110 days
- Clearance type
- Traditional
- Product code
- KHQ
- Device class
- 2
- Regulation number
- 862.1715
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Rockland, MA, 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 |
|---|---|---|
| ACE T UPTAKE REAGENT TU CALIBRATORS (K981375) | Schiapparelli Biosystems, Inc. | 1998-06-10 |
| T-UPTAKE MICROPLATE EIA (K980088) | Monobind | 1998-02-04 |
| CHIRON DIAGNOSTICS ACS:180TU P (K970539) | Chiron Diagnostics Corp. | 1997-03-24 |
| VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025) (K964308) | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-11-27 |
| ELECSYS T-UPTAKE ASSAY (K961488) | Boehringer Mannheim Corp. | 1996-06-12 |
| CEDIA T UPTAKE ASSAY (K954807) | Boehringer Mannheim Corp. | 1995-12-21 |
| T-UPTAKE EIA TEST (K951586) | Diagnostic Reagents, Inc. | 1995-05-15 |
| STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY (K933414) | Baxter Diagnostics, Inc. | 1994-11-22 |
| AXSYM(TM) T-UPTAKE (K934312) | Abbott Laboratories | 1994-06-21 |
| T3 UPTAKE CHEMILUMINESCENCE ASSAY (K926220) | Nichols Institute Diagnostics | 1993-11-17 |
| IQ TUPTAKE ASSAY (K931294) | Becton Dickinson Advanced Diagnostics | 1993-07-22 |
| COBAS(R)-FP REAGENTS FOR T-UPTAKE/CALIBRATORS (K926443) | Roche Diagnostic Systems, Inc. | 1993-05-20 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VITEK 2 SYSTEM, MODELS VITEK 2 AND VITEK 2 XL (N50510/S146) | Biomerieux Vitek, Inc. | 2001-10-17 |
| VITEK 2 GRAM POSITIVE AST PANEL FOR STREPTOCOCCUS PNEUMONIAE: TRIMETHOPRIM/SULFAMETHOXAZOLE (N50510/S145) | Biomerieux Vitek, Inc. | 2001-06-25 |
| VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR GATIFLOXACIN (N50510/S143) | Biomerieux Vitek, Inc. | 2001-06-13 |
| VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR QUINUPRISTIN/DALFOPRISTIN (N50510/S144) | Biomerieux Vitek, Inc. | 2001-06-13 |
| VITEK GRAM POSITIVE AST FOR MOXIFLOXACIN (N50510/S142) | Biomerieux Vitek, Inc. | 2001-05-30 |
| VITEK 2 GRAM POSITIVE AST FOR SPARFLOXACIN (N50510/S141) | Biomerieux Vitek, Inc. | 2001-05-14 |
| VITEK(R) 2 GRAM POSITIVE AST FOR MINOCYCLINE (N50510/S140) | Biomerieux Vitek, Inc. | 2001-03-09 |
| VITEK 2 GRAM POSITIVE AST FOR VANCOMYCIN (N50510/S138) | Biomerieux Vitek, Inc. | 2000-08-11 |