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FDA 510(k) Application Details - K000489
Device Classification Name
Extractable Antinuclear Antibody, Antigen And Control
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510(K) Number
K000489
Device Name
Extractable Antinuclear Antibody, Antigen And Control
Applicant
HELIX DIAGNOSTICS, INC.
3148 INDUSTRIAL BLVD.
WEST SACRAMENTO, CA 95691-6221 US
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Contact
VIRGINIA CAPPEL
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Regulation Number
866.5100
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Classification Product Code
LLL
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More FDA Info for this Product Code
Date Received
02/14/2000
Decision Date
04/05/2000
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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