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FDA 510(k) Application Details - K965110
Device Classification Name
C-Reactive Protein, Antigen, Antiserum, And Control
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510(K) Number
K965110
Device Name
C-Reactive Protein, Antigen, Antiserum, And Control
Applicant
CRESTAT DIAGNOSTICS, INC.
374 GOODHILL RD.
WESTON, CT 06883 US
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Contact
MARY REES
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Regulation Number
866.5270
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Classification Product Code
DCK
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Date Received
12/20/1996
Decision Date
07/03/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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