510(k) K112125 ยท NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT
| Applicant | Meridian Bioscience, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Dec 5, 2011 |
| Received | Jul 25, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112125
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.