FDA 510(k) Application Details - K962976

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

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510(K) Number K962976
Device Name System, Test, Radioallergosorbent (Rast) Immunological
Applicant PHARMACIA & UPJOHN CO.
3 BETHESDA METRO CENTER
SUITE 750
BETHESDA, MD 20814 US
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Contact JOYCE DAVIS
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Regulation Number 866.5750

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Classification Product Code DHB
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Date Received 07/31/1996
Decision Date 12/23/1996
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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