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510(k) K802615

EMIT-STM OPIATE ASSAY by Syva Co. — Product Code DJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1980
Date Received
October 20, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thin Layer Chromatography, Salicylate
Device Class
Class II
Regulation Number
862.3830
Review Panel
TX
Submission Type

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