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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hexokinase, Glucose
510(k) Number K080123
Device Name APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201
Applicant
WAKO CHEMICALS USA, INC.
1600 BELLWOOD ROAD
RICHMOND,  VA  23237
Applicant Contact PETER PANFILI
Correspondent
WAKO CHEMICALS USA, INC.
1600 BELLWOOD ROAD
RICHMOND,  VA  23237
Correspondent Contact PETER PANFILI
Regulation Number862.1345
Classification Product Code
CFR  
Subsequent Product Code
LCP  
Date Received01/17/2008
Decision Date 07/17/2008
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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