FDA 510(k) Application Details - K962341

Device Classification Name Immunochemical, Thyroglobulin Autoantibody

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510(K) Number K962341
Device Name Immunochemical, Thyroglobulin Autoantibody
Applicant HYCOR BIOMEDICAL, INC.
7272 CHAPMAN AVE.
GARDEN GROVE, CA 92841 US
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Contact MEHDI ALEM
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Regulation Number 866.5870

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Classification Product Code JNL
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Date Received 06/18/1996
Decision Date 11/25/1996
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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