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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose Oxidase, Glucose
510(k) Number K001092
Device Name GENERIC BLOOD GLUCOSE TEST STRIP
Applicant
INBIOS INTL., INC.
562 1ST. AVE. SOUTH, SUITE 600
SEATTLE,  WA  98104
Applicant Contact ESTELA I RAYCHAUDHURI
Correspondent
INBIOS INTL., INC.
562 1ST. AVE. SOUTH, SUITE 600
SEATTLE,  WA  98104
Correspondent Contact ESTELA I RAYCHAUDHURI
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Code
NBW  
Date Received04/04/2000
Decision Date 07/26/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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