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FDA 510(k) Application Details - K102908
Device Classification Name
Plasma, Coagulation Factor Deficient
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510(K) Number
K102908
Device Name
Plasma, Coagulation Factor Deficient
Applicant
R2 DIAGNOSTICS, INC.
1801 COMMERCE DR.
SOUTH BEND, IN 46628 US
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Contact
MARC D GOLDFORD
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Regulation Number
864.7290
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Classification Product Code
GJT
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More FDA Info for this Product Code
Date Received
10/01/2010
Decision Date
12/19/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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