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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 K033847
Device Name A1CNOW FOR HOME AND PROFESSIONAL USE
Applicant
METRIKA, INC.
510 OAKMEAD PKWY.
SUNNYVALE,  CA  94085 -4022
Applicant Contact ERIKA AMMIRATI
Correspondent
METRIKA, INC.
510 OAKMEAD PKWY.
SUNNYVALE,  CA  94085 -4022
Correspondent Contact ERIKA AMMIRATI
Regulation Number864.7470
Classification Product Code
LCP  
Date Received12/11/2003
Decision Date 12/23/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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