The following data is part of a premarket notification filed by Focus Diagnostics, Inc. with the FDA for Stratify Jcv Dxselect.
| Device ID | K120986 |
| 510k Number | K120986 |
| Device Name: | STRATIFY JCV DXSELECT |
| Classification | Anti-jcv Antibody Detection Assay |
| Applicant | FOCUS DIAGNOSTICS, INC. 11331 Valley View Street Cypress, CA 90630 |
| Contact | Tara Viviani |
| Correspondent | Tara Viviani FOCUS DIAGNOSTICS, INC. 11331 Valley View Street Cypress, CA 90630 |
| Product Code | OYP |
| CFR Regulation Number | 866.3336 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-02 |
| Decision Date | 2012-08-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20816101022261 | K120986 | 000 |
| 20816101022254 | K120986 | 000 |