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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 v leiden mutations, genomic dna pcr
510(k) Number K033607
Device Name FACTOR V LEIDEN KIT
Original Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
indianapolis,  IN  46250
Original Contact robert a gregg
Regulation Number864.7280
Classification Product Code
NPQ  
Date Received11/17/2003
Decision Date 12/17/2003
Decision de novo petitions granted (AN)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
FOI Item Approval Letter
Type De Novo Petitions Granted
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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