BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX
FDA 510(k) clearance DEN070006 · decided 2007-06-13
Clearance details
- K-number
- DEN070006
- Device name
- BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX
- Applicant
- Inverness Medical Professional Diagnostics-Binax
- Decision
- Unknown
- Date received
- 2007-03-23
- Decision date
- 2007-06-13
- Days to decision
- 82 days
- Clearance type
- Post-NSE
- Product code
- OAX
- Device class
- 2
- Regulation number
- 866.3402
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Scarborough, ME, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Inverness Medical Professional Diagnostics-Binax
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Recalls involving this device
No recalls on record reference this clearance.