510(k) K190613 ยท POC System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen
BD MAX Check-Points CPO
| Applicant | Check-Points Health B.V., Wageningen, NL |
| Decision | Substantially Equivalent, Aug 29, 2019 |
| Received | Mar 11, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190613
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.