510(k) K123127 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406
| Applicant | Maine Standards Co., Windham ME, US |
| Decision | Substantially Equivalent, Jun 14, 2013 |
| Received | Oct 4, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123127
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.