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510(k) K941596

REMEDI HS DRUG PROFILING SYSTEM by Bio-Rad — Product Code DNI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1995
Date Received
April 1, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Liquid Chromatography, Amphetamine
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type

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