FDA 510(k) Application Details - K962274

Device Classification Name System, Test, Radioallergosorbent (Rast) Immunological

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510(K) Number K962274
Device Name System, Test, Radioallergosorbent (Rast) Immunological
Applicant PHARMACIA, INC.
5094 ST. ANDREWS DR.
WESTERVILE, OH 43082 US
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Contact KAREN E MATIS
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Regulation Number 866.5750

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Classification Product Code DHB
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Date Received 06/13/1996
Decision Date 09/12/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee IM - Immunology
Review Advisory Committee IM - Immunology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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