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FDA 510(k) Application Details - K964341
Device Classification Name
Antibodies, Gliadin
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510(K) Number
K964341
Device Name
Antibodies, Gliadin
Applicant
IMMCO DIAGNOSTICS, INC.
963 KENMORE AVE.
BUFFALO, NY 14223 US
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Contact
RICHARD E GRECO
Other 510(k) Applications for this Contact
Regulation Number
866.5750
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Classification Product Code
MST
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More FDA Info for this Product Code
Date Received
10/31/1996
Decision Date
05/30/1997
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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