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510(k) K013882

OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I by OraSure Technologies, Inc. — Product Code JXM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2002
Date Received
November 23, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Benzodiazepine
Device Class
Class II
Regulation Number
862.3170
Review Panel
TX
Submission Type

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