510(k) K935554 ยท GTZ Antisera, All Groups, Streptococcus Spp.
QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAY
| Applicant | Syntron Bioresearch, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Aug 30, 1995 |
| Received | Nov 17, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935554
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.