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FDA 510(k) Application Details - K954894
Device Classification Name
Extractable Antinuclear Antibody, Antigen And Control
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510(K) Number
K954894
Device Name
Extractable Antinuclear Antibody, Antigen And Control
Applicant
HYCOR BIOMEDICAL, INC.
7272 CHAPMAN AVE.
GARDEN GROVE, CA 92841 US
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Contact
THOMAS M LI
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Regulation Number
866.5100
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Classification Product Code
LLL
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Date Received
09/19/1995
Decision Date
03/20/1996
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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