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510(k) K002375

STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I by OraSure Technologies, Inc. — Product Code LDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2001
Date Received
August 4, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Cannabinoids
Device Class
Class II
Regulation Number
862.3870
Review Panel
TX
Submission Type

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