510(k) K092587 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM
| Applicant | Bio-Rad Laboratories, Benicia CA, US |
| Decision | Substantially Equivalent, Dec 3, 2010 |
| Received | Aug 24, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092587
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.