FDA 510(k) Application Details - K955603

Device Classification Name Extractable Antinuclear Antibody, Antigen And Control

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510(K) Number K955603
Device Name Extractable Antinuclear Antibody, Antigen And Control
Applicant IMMUNO CONCEPTS, INC.
9779 BUSINESS PARK DR.
SUITE D
SACRAMENTO, CA 95827 US
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Contact ERIC S HOY
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Regulation Number 866.5100

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Classification Product Code LLL
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Date Received 12/08/1995
Decision Date 04/19/1996
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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