510(k) K130053 ยท MVM Autoantibodies, Endomysial(Tissue Transglutaminase)
BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI
| Applicant | Bio-Rad Laboratories, Inc., Benicia CA, US |
| Decision | Substantially Equivalent, Sep 19, 2013 |
| Received | Jan 15, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130053
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.