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FDA 510(k) Application Details - K992528
Device Classification Name
Ige, Antigen, Antiserum, Control
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510(K) Number
K992528
Device Name
Ige, Antigen, Antiserum, Control
Applicant
BIOCHECK, INC.
9418 LASAINE AVE.
NORTHRIDGE, CA 91325 US
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Contact
ROBIN J HELLEN
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Regulation Number
866.5510
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Classification Product Code
DGC
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More FDA Info for this Product Code
Date Received
07/28/1999
Decision Date
09/21/1999
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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