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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 K011616
Device Name INDUO BLOOD GLUCOSE METER
Applicant
INVERNESS MEDICAL INNOVATIONS, INC.
51 SAWYER RD., SUITE 200
WALTHAM,  MA  02453 -3448
Applicant Contact CAROL A ADILETTO
Correspondent
INVERNESS MEDICAL INNOVATIONS, INC.
51 SAWYER RD., SUITE 200
WALTHAM,  MA  02453 -3448
Correspondent Contact CAROL A ADILETTO
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   FMF  
Date Received05/25/2001
Decision Date 06/21/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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