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CLIA - Clinical Laboratory Improvement Amendments

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Test System NameFora Care Inc., FORA V12 Blood Glucose Monitoring System  
Document Number K090404
Analyte NameGlucose Monitoring Devices (FDA Cleared/Home Use)
Analyte SpecialtyGeneral Chemistry
ComplexityWAIVED
Effective Date07/16/2009
Device Classification Name system, test, blood glucose, over the counter
510(k) NumberK090404
Device NameFORE V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244, FOREA V12 BLODO GLUCOSE MONITORING SYSTEM, MODEL TD-4247
Applicant
TAIDOC TECHNOLOGY CORPORATION
6f, no. 127, wugong 2nd rd
wugu township
taipei county, 
Contactyuhua chen
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received02/17/2009
Decision Date 06/23/2009
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Statement/Summary/Purged Status Statement only
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Expedited Review No
 
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