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510(k) K092268

RANDOX BARITURATES ASSAY by Randox Laboratories, Ltd. — Product Code DIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2011
Date Received
July 28, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Barbiturate
Device Class
Class II
Regulation Number
862.3150
Review Panel
TX
Submission Type

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