510(k) K152679 ยท PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak
| Applicant | Bio-Rad Laboratories, Irvine CA, US |
| Decision | Substantially Equivalent, May 10, 2016 |
| Received | Sep 18, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152679
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.