510(k) K100747 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
CONTREX PLUS LOW CONTROL SOLUTION
| Applicant | Apex BioTechnology Corp., Hsinchu, TW |
| Decision | Substantially Equivalent, Apr 14, 2010 |
| Received | Mar 16, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100747
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.