VIDAS TOXO IGG AVIDITY
FDA 510(k) clearance K101946 · decided 2011-05-18
Clearance details
- K-number
- K101946
- Device name
- VIDAS TOXO IGG AVIDITY
- Applicant
- bioMerieux, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-07-12
- Decision date
- 2011-05-18
- Days to decision
- 310 days
- Clearance type
- Traditional
- Product code
- LGD
- Device class
- 2
- Regulation number
- 866.3780
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Hazelwood, MO, US
- Third-party review
- No
- Expedited review
- No
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| LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II (K132234) | DiaSorin, Inc. | 2013-08-28 |
| LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II (K131441) | DiaSorin, Inc. | 2013-08-09 |
| ADVIA CENTAUR TOXOPLASMA IGG (TOXO G) (K102681) | Siemens Healthcare Diagnostics, Inc. | 2011-05-04 |
| PLATELIA TOXO IGM KIT MODEL 26211 (K090847) | Bio-Rad Laboratories | 2009-07-01 |
| ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG (K073501) | Roche Diagnostics Corp. | 2008-06-09 |
| ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC (K080869) | Beckman Coulter, Inc. | 2008-05-23 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| THXID-BRAF (P120014/S012) | bioMerieux, Inc. | 2021-12-20 |
| THxID-BRAF kit (P120014/S011) | bioMerieux, Inc. | 2021-03-10 |
| THxID-BRAF assay kit (P120014/S010) | bioMerieux, Inc. | 2020-02-26 |
| THxID BRAF assay kit (P120014/S009) | bioMerieux, Inc. | 2019-08-26 |
| THxID BRAF assay kit (P120014/S008) | bioMerieux, Inc. | 2018-06-27 |
| THxID-BRAF kit (P120014/S007) | bioMerieux, Inc. | 2016-11-22 |
| VIDAS TOTAL PSA (P040008/S013) | bioMerieux, Inc. | 2016-05-31 |
| THXID-BRAF KIT (P120014/S006) | bioMerieux, Inc. | 2016-04-05 |