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FDA 510(k) Application Details - K964300
Device Classification Name
Complement C4, Antigen, Antiserum, Control
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510(K) Number
K964300
Device Name
Complement C4, Antigen, Antiserum, Control
Applicant
CRESTAT DIAGNOSTICS, INC.
25549 ADAMS AVE.
MURRIETA, CA 92562 US
Other 510(k) Applications for this Company
Regulation Number
866.5240
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Classification Product Code
DBI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/29/1996
Decision Date
07/14/1997
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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