510(k) K062957 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
FASTPACK TOTAL PSA METHOD VERIFICATION KIT
| Applicant | Qualigen, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Apr 2, 2007 |
| Received | Sep 29, 2006 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K062957
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.