NUCLISENS EASYQ ENTEROVIRUS SYSTEM
FDA 510(k) clearance K063261 · decided 2008-06-23
Clearance details
- K-number
- K063261
- Device name
- NUCLISENS EASYQ ENTEROVIRUS SYSTEM
- Applicant
- bioMerieux, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-10-30
- Decision date
- 2008-06-23
- Days to decision
- 602 days
- Clearance type
- Traditional
- Product code
- OAI
- Device class
- 2
- Regulation number
- 866.3225
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Durham, NC, 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 |
|---|---|---|
| XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065 (DEN070004) | Cepheid | 2007-03-16 |
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 |