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FDA 510(k) Application Details - K013432
Device Classification Name
Anti-Dna Indirect Immunofluorescent Solid Phase
More FDA Info for this Device
510(K) Number
K013432
Device Name
Anti-Dna Indirect Immunofluorescent Solid Phase
Applicant
IMMUNO CONCEPTS, INC.
9779 BUSINESS PARK DR.
SUITE D
SACRAMENTO, CA 95827 US
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Contact
ERIC S HOY
Other 510(k) Applications for this Contact
Regulation Number
866.5100
More FDA Info for this Regulation Number
Classification Product Code
KTL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/15/2001
Decision Date
11/29/2001
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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