510(k) K092349 ยท PSZ Devices Detecting Influenza A, B, And C Virus Antigens
CLEARVIEW EXACT II INFLUENZA A & B TEST
| Applicant | Inverness Medical, Inc., Scarborough ME, US |
| Decision | Substantially Equivalent, May 10, 2010 |
| Received | Aug 4, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092349
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.