STRATIFY JCV DXSELECT
FDA 510(k) clearance K120986 · decided 2012-08-16
Clearance details
- K-number
- K120986
- Device name
- STRATIFY JCV DXSELECT
- Applicant
- Focus Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-04-02
- Decision date
- 2012-08-16
- Days to decision
- 136 days
- Clearance type
- Traditional
- Product code
- OYP
- Device class
- 2
- Regulation number
- 866.3336
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cypress, CA, 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 |
|---|---|---|
| STRATIFY JCV(TM) ANTIBODY (DEN120008) | Focus Diagnostics, Inc. | 2012-01-20 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in recall (Z-1454-2015) | Focus Diagnostics Inc | 2015-04-17 |