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510(k) K920314

TXIT D.A.U. BARBITURATE ASSAY (MODIFICATION) by Syntex Corp. — Product Code DIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 1992
Date Received
January 23, 1992
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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