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FDA 510(k) Application Details - K964294
Device Classification Name
Alpha-1-Lipoprotein, Antigen, Antiserum, Control
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510(K) Number
K964294
Device Name
Alpha-1-Lipoprotein, Antigen, Antiserum, Control
Applicant
CRESTAT DIAGNOSTICS, INC.
25549 ADAMS AVE.
MURRIETA, CA 92562 US
Other 510(k) Applications for this Company
Regulation Number
866.5580
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Classification Product Code
DER
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/29/1996
Decision Date
08/01/1997
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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