510(k) K103834 ยท MID System, Test, Anticardiolipin Immunological
BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS
| Applicant | Bio-Rad Laboratories, Benicia CA, US |
| Decision | Substantially Equivalent, Mar 30, 2012 |
| Received | Dec 30, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103834
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.