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510(k) K071644

ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620 by Roche Diagnostics Corp. — Product Code DLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2007
Date Received
June 15, 2007
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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