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FDA 510(k) Application Details - K972835
Device Classification Name
Calibrators, Drug Specific
More FDA Info for this Device
510(K) Number
K972835
Device Name
Calibrators, Drug Specific
Applicant
DIAGNOSTIC REAGENTS, INC.
601 CALIFORNIA AVE.
SUNNYVALE, CA 94086 US
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Contact
YUH-GENG TSAY
Other 510(k) Applications for this Contact
Regulation Number
862.3200
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Classification Product Code
DLJ
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More FDA Info for this Product Code
Date Received
07/31/1997
Decision Date
08/28/1997
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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