510(k) K080008 ยท OMI Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv
BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET
| Applicant | Bio-Rad Laboratories, Inc., North Attleboro MA, US |
| Decision | Substantially Equivalent, Feb 23, 2009 |
| Received | Jan 2, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080008
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.