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FDA 510(k) Application Details - K000336
Device Classification Name
Autoantibodies,Skin(Desmoglein 1 And Desmoglein 3)
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510(K) Number
K000336
Device Name
Autoantibodies,Skin(Desmoglein 1 And Desmoglein 3)
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
866.5660
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Classification Product Code
NBO
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More FDA Info for this Product Code
Date Received
02/03/2000
Decision Date
06/09/2000
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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