510(k) K854081 ยท GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
IMAGEN RESPIRATORY SYNCYTIAL VIRUS TEST
| Applicant | Boots-Celltech Diagnostics, Inc., Berkshire, England, GB |
| Decision | Substantially Equivalent, Jan 3, 1986 |
| Received | Oct 7, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854081
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.