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510(k) K011303

RANDOX PHENOBARBITAL by Randox Laboratories, Ltd. — Product Code DLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2001
Date Received
April 30, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Phenobarbital
Device Class
Class II
Regulation Number
862.3660
Review Panel
TX
Submission Type

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