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510(k) K041143

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2004
Date Received
April 30, 2004
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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