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510(k) K011057

INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX by OraSure Technologies, Inc. — Product Code PJD

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 6, 2001
Date Received: April 6, 2001
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
Device Class: Class II
Regulation Number: 862.1675
Review Panel: CH
Submission Type

Intended for use in the collection, preservation, and transport of oral fluid specimens for drugs of abuse or alcohol testing.

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