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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 K031296
Device Name LIQUI-HEME GLYCO A1C ASSAY
Applicant
Biodiagnostic Intl
615 N. Berry St.
# E
Brea,  CA  92821
Applicant Contact PAUL ANAND
Correspondent
Biodiagnostic Intl
615 N. Berry St.
# E
Brea,  CA  92821
Correspondent Contact PAUL ANAND
Regulation Number864.7470
Classification Product Code
LCP  
Subsequent Product Codes
JJX   KRZ  
Date Received04/23/2003
Decision Date 10/15/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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