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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 K020235
Device Name A1CNOW FOR PROFESSIONAL USE
Applicant
Metrika, Inc.
510 Oakmead Pkwy.
Sunnyvale,  CA  94085
Applicant Contact ERIKA AMMIRATI
Correspondent
Metrika, Inc.
510 Oakmead Pkwy.
Sunnyvale,  CA  94085
Correspondent Contact ERIKA AMMIRATI
Regulation Number864.7470
Classification Product Code
LCP  
Date Received01/23/2002
Decision Date 02/15/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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