510(k) DEN070006
- Device
- BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX
- Applicant
- Inverness Medical Professional Diagnostics-Binax
- 510(k) number
- DEN070006
- Product code
- OAX
- Decision
- Unknown (DENG)
- Decision date
- 2007-06-13
- Date received
- 2007-03-23
- Regulation
- 866.3402
- Classification name
- Plasmodium Spp. Detection Reagents
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- Anne Jepson
- Address
- 10 Southgate Rd. Scarborough ME US 04074 04074
FDA Registration Numbers#
- 3005360469
- 3011561946
- 1221359
- 1318354
- 3024753119
- 3017662853
- 2032682
- 3024756665
- 3017013438
Source Documents#
510(k) summary PDF not indicated by FDA