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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK102383
Test Name Cambridge Sensors USA microdot Home Blood Glucose Monitoring System  
Manufacturer NameCAMBRIDGE SENSORS LIMITED
Consumer Information Phone Number(877)374-4062
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date01/31/2012
Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K102383
Device Name MICRODOT & MICRODOT XTRA
Applicant
CAMBRIDGE SENSORS LIMITED
UNITS 9&10 CARDINAL PARK
GODMANCHESTER
HUNTINGDON, CAMBRIDGESHIRE,  GB PE29 2XG
Applicant Contact BERNADETTE YON-HIN
Correspondent
CAMBRIDGE SENSORS LIMITED
UNITS 9&10 CARDINAL PARK
GODMANCHESTER
HUNTINGDON, CAMBRIDGESHIRE,  GB PE29 2XG
Correspondent Contact BERNADETTE YON-HIN
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
LFR  
Date Received08/23/2010
Decision Date 01/27/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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