The following data is part of a De Novo classification by Inverness Medical Professional Diagnostics-binax with the FDA for Binax Now Malaria Test; Model 660-000, 660-xxx.
| DeNovo ID | DEN070006 |
| Device Name: | BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX |
| Classification | Plasmodium Spp. Detection Reagents |
| Applicant | INVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS-BINAX 10 Southgate Rd. Scarborough, ME 04074 |
| Contact | Anne Jepson |
| Product Code | OAX |
| CFR Regulation Number | 866.3402 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K061542 |
| Review Advisory Board | Microbiology |
| Classification Advisory | Microbiology |
| Type | Post-NSE |
| Date Received | 2007-03-23 |
| Decision Date | 2007-06-13 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10811877010378 | DEN070006 | 000 |
| 10811877010361 | DEN070006 | 000 |