FDA 510(k) Application Details - K091522

Device Classification Name Antibodies, Gliadin

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510(K) Number K091522
Device Name Antibodies, Gliadin
Applicant IMMCO DIAGNOSTICS, INC.
60 PINEVIEW DR.
BUFFALO, NY 14228-2120 US
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Contact KEVIN LAWSON
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Regulation Number 866.5750

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Classification Product Code MST
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Date Received 05/22/2009
Decision Date 02/04/2010
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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