510(k) K912838 ยท LKT Respiratory Syncytial Virus, Antigen, Antibody, Ifa
BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO
| Applicant | Baxter Diagnostics, Inc., Bellevue WA, US |
| Decision | Substantially Equivalent, Sep 27, 1991 |
| Received | Jun 26, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912838
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.