510(k) K022504 ยท NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
IDI-STREP B ASSAY
| Applicant | Infectio Diagnostic, Inc., Baldwin MD, US |
| Decision | Substantially Equivalent, Nov 18, 2002 |
| Received | Jul 29, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022504
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.