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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
510(k) Number K033612
Device Name FACTOR II (PROTHROMBIN) G20210A KIT
Applicant
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS,  IN  46250
Applicant Contact ROBERT A GREGG
Correspondent
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS,  IN  46250
Correspondent Contact ROBERT A GREGG
Regulation Number864.7280
Classification Product Code
NPR  
Date Received11/17/2003
Decision Date 12/18/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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