BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX— 510(k) DEN070006

Name: FDA 510(k) clearance DEN070006
Creator: U.S. Food and Drug Administration
Published: 2007-06-13

Unknown

Inverness Medical Professional Diagnostics-Binax

FDA 510(k) clearance DEN070006 for BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX, Unknown on 2007-06-13. Applicant: Inverness Medical Professional Diagnostics-Binax. Device class: 2.

Clearance details

Applicant: Inverness Medical Professional Diagnostics-Binax
Product code: Code OAX
Device class: Class 2
Regulation: 21 CFR 866.3402
Advisory panel: Microbiology
Date received: 2007-03-23
Decision date: 2007-06-13
Decision: Unknown
Clearance type: Post-NSE
Location: Scarborough, ME, US

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