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FDA 510(k) Application Details - K032804
Device Classification Name
Control, Plasma, Abnormal
More FDA Info for this Device
510(K) Number
K032804
Device Name
Control, Plasma, Abnormal
Applicant
PRECISION BIOLOGIC
900 WINDMILL RD., SUITE 100
DARTMOUTH, N.S. B3B 1P7 CA
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Contact
STEPHEN DUFF
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Regulation Number
864.5425
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Classification Product Code
GGC
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More FDA Info for this Product Code
Date Received
09/09/2003
Decision Date
11/03/2003
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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