510(k) K062211 ยท LSE Epstein-Barr Virus, Other
BIOPLEX 2200 EBV IGG PANEL FOR 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 K062211
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 27, 2011 | Bio-Rad Laboratories BioPlex 2200 EBV IgG Calibrator Set. Catalog #663-1200.
Product is labeled in part: "BIO-RAD***BioPlex 2200 EBV IgG Calibrator Set***7 x 0.5 mL***A Calibrator set for the BioPlex 2200 EBV IgG Reagen Terminated |
LSE | None listed |
| Jun 11, 2008 | Bio-Rad Laboratories BIOPLEX 2200 EBV IgG KIT, CALIBRATORS, AND CONTROLS: 100 tests - Catalog No. 665-1250 - manufactured by Bio-Rad Laboratories in Redmond, WA 98052. The product is multiflow immunoassay intended for th Terminated |
LSE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.