510(k) K882629 ยท GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
DIRECTIGEN RESPIRATORY SYNCYTIAL VIRUS TEST KIT
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic, Franklin Lakes NJ, US |
| Decision | Substantially Equivalent, Oct 31, 1988 |
| Received | Jun 27, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K882629
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.