510(k) K092300 ยท GNW Antisera, Cf, Influenza Virus A, B, C
MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT
| Applicant | Diagnostic Hybrids, Inc., Athens OH, US |
| Decision | Substantially Equivalent, Aug 28, 2009 |
| Received | Jul 29, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K092300
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.