510(k) DEN070006
DEN070006 is an FDA 510(k) premarket notification submitted by Inverness Medical Professional Diagnostics-Binax for the device "BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX". The FDA issued a decision of De Novo Granted on June 13, 2007. The device falls under product code OAX (Plasmodium Spp. Detection Reagents), a Class II device regulated under 21 CFR 866.3402.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- June 13, 2007
- Date Received
- March 23, 2007
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plasmodium Spp. Detection Reagents
- Device Class
- Class II
- Regulation Number
- 866.3402
- Review Panel
- MI
- Submission Type
For the detection of plasmodium spp. Antigens in venous or capillary whole blood. To aid in the diagnosis of human malaria infections and/or to aid in the differential diagnosis of plasmodium falciparum infections from other less virulent plasmodium species.