510(k) DEN120008
- Device
- STRATIFY JCV(TM) ANTIBODY
- Applicant
- Focus Diagnostics, Inc.
- 510(k) number
- DEN120008
- Product code
- OYP
- Decision
- Unknown (DENG)
- Decision date
- 2012-01-20
- Date received
- 2012-01-06
- Regulation
- 866.3336
- Classification name
- Anti-Jcv Antibody Detection Assay
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- TARA VIVIANI
- Address
- 11331 Valley View St. Cypress CA US 90630 90630
FDA Registration Numbers#
- 2023365
- 2027113
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code OYP#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K120986 | STRATIFY JCV DXSELECT | Focus Diagnostics, Inc. | 2012-08-16 |