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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name assay, glycosylated hemoglobin
510(k) Number K090413
FOIA Releasable 510(k) K090413
Device Name A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC
Applicant
BAYER HEALTHCARE, LLC
510 OAKMEAD PKWY.
SUNNYVALE,  CA  94085
Applicant Contact CATHY PETERS
Correspondent
BAYER HEALTHCARE, LLC
510 OAKMEAD PKWY.
SUNNYVALE,  CA  94085
Correspondent Contact CATHY PETERS
Regulation Number864.7470
Classification Product Code
LCP  
Date Received02/18/2009
Decision Date 05/14/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Clinical Trials NCT00798486
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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