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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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More FDA Info for this Product Code
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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