510(k) K120986
- Device
- STRATIFY JCV DXSELECT
- Applicant
- FOCUS DIAGNOSTICS, INC.
- 510(k) number
- K120986
- Product code
- OYP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-08-16
- Date received
- 2012-04-02
- Regulation
- 866.3336
- Classification name
- Anti-jcv Antibody Detection Assay
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- TARA VIVIANI
- Address
- 11331 Valley View St. Cypress CA US 90630 90630
FDA Registration Numbers#
- 2023365
- 2027113
Source Documents#
Other 510(k) Records For Product Code OYP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN120008 | STRATIFY JCV(TM) ANTIBODY | Focus Diagnostics, Inc. | 2012-01-20 |
Legacy Summary#
summary
FDA Review#
Decision Summary