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FDA 510(k) Application Details - K132082
Device Classification Name
Antibodies, Gliadin
More FDA Info for this Device
510(K) Number
K132082
Device Name
Antibodies, Gliadin
Applicant
AESKU.DIAGNOSTICS
MIKROFORUM RING 2
WENDELSHEIM D-55234 DE
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Contact
SASCHA PFEIFFER
Other 510(k) Applications for this Contact
Regulation Number
866.5750
More FDA Info for this Regulation Number
Classification Product Code
MST
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/05/2013
Decision Date
12/05/2013
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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