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FDA 510(k) Application Details - K021208
Device Classification Name
System, Test, Radioallergosorbent (Rast) Immunological
More FDA Info for this Device
510(K) Number
K021208
Device Name
System, Test, Radioallergosorbent (Rast) Immunological
Applicant
DIAGNOSTIC PRODUCTS CORP.
5700 WEST 96TH ST.
LOS ANGELES, CA 90045-5597 US
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Contact
ROBERT M DI TULLIO
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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
04/16/2002
Decision Date
05/30/2002
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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