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FDA 510(k) Application Details - K964787
Device Classification Name
Extractable Antinuclear Antibody, Antigen And Control
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510(K) Number
K964787
Device Name
Extractable Antinuclear Antibody, Antigen And Control
Applicant
MARDX DIAGNOSTICS, INC.
5919 FARNSWORTH CT.
CARLSBAD, CA 92008 US
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Contact
ARTHUR MARKOVITS
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Regulation Number
866.5100
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Classification Product Code
LLL
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Date Received
11/29/1996
Decision Date
04/08/1997
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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