510(k) K090191 ยท NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
HANDYLAB GBS ASSAY, HANDYLAB JAGUAR INSTRUMENT, HANDYLAB DNA EXTRACTION STRIP, HANDYLAB E3 EXTRACTION REAGENT, HANDYLAB
| Applicant | Handylab, Inc., Ann Arbor MI, US |
| Decision | Substantially Equivalent, May 27, 2010 |
| Received | Jan 27, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090191
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.