510(k) K093116 ยท PSZ Devices Detecting Influenza A, B, And C Virus Antigens
MODIFICATION TO: RAMP INFLUENZA A/B ASSAY
| Applicant | Response Biomedical Corp., Vancouver, B.C, CA |
| Decision | Substantially Equivalent, Oct 21, 2009 |
| Received | Oct 2, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K093116
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.