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FDA 510(k) Application Details - K031308
Device Classification Name
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
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510(K) Number
K031308
Device Name
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Applicant
RHIGENE, INC.
12061 TEJON ST.
WESTMINSTER, CO 80234 US
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Contact
NANCI DEXTER
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Regulation Number
866.5090
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Classification Product Code
DBM
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Date Received
04/24/2003
Decision Date
09/26/2003
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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