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FDA 510(k) Application Details - K000751
Device Classification Name
Extractable Antinuclear Antibody, Antigen And Control
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510(K) Number
K000751
Device Name
Extractable Antinuclear Antibody, Antigen And Control
Applicant
RHIGENE, INC.
455 STATE ST.,
SUITE 104
DES PLAINES, IL 60068 US
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Contact
DAVE KOLESAR
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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
03/08/2000
Decision Date
05/09/2000
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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