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FDA 510(k) Application Details - K030590
Device Classification Name
System, Test, Radioallergosorbent (Rast) Immunological
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510(K) Number
K030590
Device Name
System, Test, Radioallergosorbent (Rast) Immunological
Applicant
HITACHI CHEMICAL DIAGNOSTICS, INC.
630 CLYDE CT.
MOUNTAIN VIEW, CA 94043 US
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Contact
MARY ANN DU BROCK
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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
02/25/2003
Decision Date
03/21/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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