510(k) K062213 ยท LSE Epstein-Barr Virus, Other
BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
| Applicant | Bio-Rad Laboratories, Inc., Redmond WA, US |
| Decision | Substantially Equivalent, Dec 8, 2006 |
| Received | Aug 1, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062213
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 11, 2008 | Bio-Rad Laboratories BIOPLEX 2200 EBV IgM KIT, CALIBRATORS, AND CONTROLS: 100 tests - Catalog No. 665-1350 - manufactured by Bio-Rad Laboratories in Redmond, WA. The product is a multiplex flow immunoassay intended for t Terminated |
LSE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.