510(k) K120169 ยท CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M)
INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT
| Applicant | Grifols USA, LLC, East Stroudsburg PA, US |
| Decision | Substantially Equivalent, Aug 24, 2012 |
| Received | Jan 19, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120169
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.