BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX

Plasmodium Spp. Detection Reagents

INVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS-BINAX

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.

Pre-market Notification Details

DeNovo IDDEN070006
Device Name:BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX
ClassificationPlasmodium Spp. Detection Reagents
Applicant INVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS-BINAX 10 Southgate Rd. Scarborough,  ME  04074
ContactAnne Jepson
Product CodeOAX  
CFR Regulation Number866.3402 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationK061542
Review Advisory BoardMicrobiology
Classification AdvisoryMicrobiology
TypePost-NSE
Date Received2007-03-23
Decision Date2007-06-13
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10811877010378 DEN070006 000
10811877010361 DEN070006 000

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