510(k) K142821 ยท PJE Blood/Plasma Collection Device For Dna Testing
PAXgene Blood DNA Tube
| Applicant | Preanalytix GmbH, Hombrechtikon, CH |
| Decision | Substantially Equivalent, Sep 9, 2015 |
| Received | Sep 30, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142821
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.