Panels › Microbiology › Product code OYP · Class 2
Anti-Jcv Antibody Detection Assay
Regulation 866.3336
0510(k)s in 12 months (2 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in OYP
| Company | 510(k)s | Recalls |
|---|---|---|
| Focus Diagnostics, Inc. | 2 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 16, 2012 | K120986 | STRATIFY JCV DXSELECT Focus Diagnostics, Inc. | OYP |
| Jan 20, 2012 | DEN120008 | STRATIFY JCV(TM) ANTIBODY Focus Diagnostics, Inc. | OYP |
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