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FDA 510(k) Application Details - K041658
Device Classification Name
Antinuclear Antibody, Antigen, Control
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510(K) Number
K041658
Device Name
Antinuclear Antibody, Antigen, Control
Applicant
BIO-RAD LABORATORIES, INC.
6565 185TH AVE., N.E.
REDMOND, WA 98052 US
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Contact
CHRISTOPHER BENSTEN
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Regulation Number
866.5100
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Classification Product Code
LKJ
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Date Received
06/18/2004
Decision Date
12/20/2004
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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