VIDAS CMV IGM ASSAY
FDA 510(k) clearance K933549 · decided 1994-08-02
Clearance details
- K-number
- K933549
- Device name
- VIDAS CMV IGM ASSAY
- Applicant
- Biomerieux Vitek, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-07-22
- Decision date
- 1994-08-02
- Days to decision
- 376 days
- Clearance type
- Traditional
- Product code
- LKQ
- Device class
- 2
- Regulation number
- 866.3175
- 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 |
|---|---|---|
| IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2, (K100433) | Siemens Healthcare Diagnostics | 2010-05-13 |
| ACCURUN 146 CMV IGM POSITIVE CONTROL (K972884) | Boston Biomedica, Inc. | 1997-08-22 |
| BARTELS CYTOMEGALOVIRUS IGM EIA (K922580) | Baxter Diagnostics, Inc. | 1993-04-08 |
| ELISA CMV IGM (K914789) | Sclavo, Inc. | 1992-03-04 |
| OPUS(R) ANTI CMV-M (K913080) | Pb Diagnostics, Inc. | 1991-10-28 |
| CMV-IGM IFA TEST SYSTEM (K900743) | Zeus Scientific, Inc. | 1990-04-26 |
| CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST) (K893465) | Immuno Concepts, Inc. | 1989-07-25 |
| CMV IGM ANTIBODY TEST (INDIRECT ENZYME TEST) (K893466) | Immuno Concepts, Inc. | 1989-07-14 |
| ABBOTT CMV-M EIA KIT (K872881) | Abbott Laboratories | 1988-05-13 |
| IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530 (K872942) | Clinical Sciences, Inc. | 1988-01-11 |
| CMV IGM MICROASSAY (K871832) | Diamedix Corp. | 1987-08-07 |
| FIAX(R) TEST KIT CYTOMEGALOVIRUS M ANTIBODIES (K863798) | Whittaker Bioproducts, Inc. | 1987-04-14 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx. recall (Z-0742-2022) | bioMerieux, Inc. | 2022-03-14 |
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 |