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FDA 510(k) Application Details - K062530
Device Classification Name
Test, Qualitative And Quantitative Factor Deficiency
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510(K) Number
K062530
Device Name
Test, Qualitative And Quantitative Factor Deficiency
Applicant
BIOSITE INCORPORATED
9975 SUMMERS RIDGE RD
SAN DIEGO, CA 92121 US
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Contact
FIL V BUENVIAJE
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Regulation Number
864.7290
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Classification Product Code
GGP
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More FDA Info for this Product Code
Date Received
08/29/2006
Decision Date
01/29/2007
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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