The following data is part of a De Novo classification by Bio-rad Laboratories with the FDA for 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.
| DeNovo ID | DEN150058 |
| Device Name: | 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 |
| Classification | Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays |
| Applicant | Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA 92614 |
| Contact | Elizabeth Platt |
| Product Code | PMN |
| CFR Regulation Number | 866.3920 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Microbiology |
| Classification Advisory | Microbiology |
| Type | Post-NSE |
| Date Received | 2015-12-16 |
| Decision Date | 2016-03-28 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661005995 | DEN150058 | 000 |
| 00847661005988 | DEN150058 | 000 |
| 00847661005971 | DEN150058 | 000 |
| 00847661005964 | DEN150058 | 000 |
| 00847661005957 | DEN150058 | 000 |
| 00847661005940 | DEN150058 | 000 |
| 00847661005933 | DEN150058 | 000 |
| 00847661005926 | DEN150058 | 000 |