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 |