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FDA 510(k) Application Details - K033612
Device Classification Name
Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
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510(K) Number
K033612
Device Name
Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
Applicant
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS, IN 46250 US
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Contact
ROBERT A GREGG
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Regulation Number
864.7280
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Classification Product Code
NPR
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More FDA Info for this Product Code
Date Received
11/17/2003
Decision Date
12/18/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
PA - Pathology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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