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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, test, blood glucose, over the counter
510(k) Number K083273
Device Name MICRODOT XTRA
Applicant
CAMBRIDGE SENSORS LIMITED
UNITS 9&10 CARDINAL PARK
GODMANCHESTER
HUNTINGDON, CAMBRIDGESHIRE,  GB PE29 2XG
Applicant Contact WARREN REEVES
Correspondent
CAMBRIDGE SENSORS LIMITED
UNITS 9&10 CARDINAL PARK
GODMANCHESTER
HUNTINGDON, CAMBRIDGESHIRE,  GB PE29 2XG
Correspondent Contact WARREN REEVES
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
JJX   LFR  
Date Received11/06/2008
Decision Date 11/19/2009
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
Recalls CDRH Recalls
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