510(k) DEN150058 ยท PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak
| Applicant | Bio-Rad Laboratories, Irvine CA, US |
| Decision | Unknown, Mar 28, 2016 |
| Received | Dec 16, 2015 |
| Type | Post-NSE |
| FDA record | Open on fda.gov |
Recalls that name DEN150058
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.