510(k) K092633 ยท PSZ Devices Detecting Influenza A, B, And C Virus Antigens
OSOM INFLUENZA A&B TEST , MODEL PN190
| Applicant | Genzyme Corporation, Cambridge MA, US |
| Decision | Substantially Equivalent, Sep 25, 2009 |
| Received | Aug 27, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K092633
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.