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510(k) K884419

TECHNICON RA-PHENOBARBITAL by Technicon Instruments Corp. — Product Code DLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1988
Date Received
October 20, 1988
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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