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FDA 510(k) Application Details - K052825
Device Classification Name
Test, Qualitative And Quantitative Factor Deficiency
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510(K) Number
K052825
Device Name
Test, Qualitative And Quantitative Factor Deficiency
Applicant
AFFINITY BIOLOGICALS INC.
1395 SANDHILL DRIVE
ANCASTER, ONTARIO L9G 4V5 CA
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Contact
DENISE FOULON
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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
10/05/2005
Decision Date
01/20/2006
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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