510(k) K122019 ยท OYZ Group A Streptococcus Nucleic Acid Amplification Assay System
STREPTOCOCCUS APP. SEROLOGICAL REAGENTS
| Applicant | Meridian Bioscience, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Sep 13, 2012 |
| Received | Jul 10, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122019
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.