VIDAS ROTAVIRUS ASSAY
FDA 510(k) clearance K965092 · decided 1997-05-05
Clearance details
- K-number
- K965092
- Device name
- VIDAS ROTAVIRUS ASSAY
- Applicant
- Biomerieux Vitek, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-12-19
- Decision date
- 1997-05-05
- Days to decision
- 137 days
- Clearance type
- Traditional
- Product code
- LIQ
- Device class
- 1
- Regulation number
- 866.3405
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- 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 |
|---|---|---|
| SAS ROTA TEST (K990842) | Sa Scientific, Inc. | 1999-08-09 |
| VIDAS ROTAVIRUS (RTV) ASSAY (K972895) | Biomerieux Vitek, Inc. | 1997-10-03 |
| IMMUNOCARD STAT! ROTAVIRUS (K971585) | Meridian Diagnostics, Inc. | 1997-08-20 |
| ROTAVIRUS EIA (K964424) | Trinity Biotech, Inc. | 1997-08-08 |
| ROTA-DAN RAPID ROTAVIRUS EIA KIT (K951208) | Eldan Technologies, Ltd. | 1996-02-14 |
| DIARLEX ROTA-ADENO (K942286) | Orion Diagnostica, Inc. | 1994-12-14 |
| IMMUNOCARD ROTAVIRUS (K933587) | Meridian Diagnostics, Inc. | 1994-02-03 |
| IDEIA(TM) ROTAVIRUS (K932384) | Dako Diagnostics , Ltd. | 1993-12-27 |
| KALLESTAD ROTAVIRUS MICROPLATE (K915137) | Bio-Rad Laboratories, Inc. | 1992-03-04 |
| DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440 (K912666) | Dako Corp. | 1992-02-14 |
| SLIDEX ROTA-KIT 2 (K895805) | Vitek Systems, Inc. | 1991-02-26 |
| ROTACUBE (K884017) | Difco Laboratories, Inc. | 1989-01-24 |
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 |