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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 K000885
Device Name DRX HBA1C - FOR PRESCRIPTION HOME USE
Applicant
Metrika, Inc.
510 Oakmead Pkwy.
Sunnyvale,  CA  94085 -4022
Applicant Contact JOEL M BLATT
Correspondent
Metrika, Inc.
510 Oakmead Pkwy.
Sunnyvale,  CA  94085 -4022
Correspondent Contact JOEL M BLATT
Regulation Number864.7470
Classification Product Code
LCP  
Date Received03/20/2000
Decision Date 09/26/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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