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FDA 510(k) Application Details - K960526
Device Classification Name
Radioimmunoassay, Amphetamine
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510(K) Number
K960526
Device Name
Radioimmunoassay, Amphetamine
Applicant
DIAGNOSTIC REAGENTS, INC.
601 CALIFORNIA AVE.
SUNNYVALE, CA 94086 US
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Contact
YUH-GENG TSAY
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Regulation Number
862.3100
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Classification Product Code
DJP
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Date Received
02/06/1996
Decision Date
03/18/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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