510(k) K063866 ยท LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
BIOPLEX 2200 SYPHILIS IGG KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
| Applicant | Bio-Rad Laboratories, Redmond WA, US |
| Decision | Substantially Equivalent, Mar 19, 2007 |
| Received | Dec 29, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063866
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 23, 2010 | Bio-Rad Laboratories BIO-RAD BioPlex 2200 Syphilis IgG Control Set. Lot # 46636
The BioPlex 2200 Syphilis IgG Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPle Terminated |
LIP | None listed |
| Jun 11, 2008 | Bio-Rad Laboratories BIOPLEX 2200 SYPHILIS IgG Kit: 100 tests - Catalog No. 665-1450 - manufactured by Bio-Rad Laboratories in Redmond, WA 98052. The product is a multiplex flow immunoassay intended for the qualitative d Terminated |
LIP | None listed |
| Nov 9, 2007 | Bio-Rad Labroatories Inc. BioPlex 2200 System, Cat. No. 665-1460A containing APF CD SW2_v1., Syphilis IgG IFU Packet contains the Syphilis IgG Assay Protocol File LAPF CD Terminated |
LIP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.