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510(k) K993208

STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104I by OraSure Technologies, Inc. — Product Code LAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2000
Date Received
September 24, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas Chromatography, Methamphetamine
Device Class
Class II
Regulation Number
862.3610
Review Panel
TX
Submission Type

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