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FDA 510(k) Application Details - K991385
Device Classification Name
C-Reactive Protein, Antigen, Antiserum, And Control
More FDA Info for this Device
510(K) Number
K991385
Device Name
C-Reactive Protein, Antigen, Antiserum, And Control
Applicant
DADE BEHRING, INC.
P.O. BOX 6101
GLASGOW BLDG. 500
NEWARK, DE 19714-6101 US
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Contact
REBECCA S AYASH
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Regulation Number
866.5270
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Classification Product Code
DCK
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More FDA Info for this Product Code
Date Received
04/21/1999
Decision Date
10/25/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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