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510(k) K942435

SALIVA SAMPLER by Saliva Diagnostic Systems, Inc. — Product Code PJD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1995
Date Received
May 20, 1994
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.

Other clearances by Saliva Diagnostic Systems, Inc.

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  • K962721 — EVIDENCE PREGNANCY TEST (October 1, 1996)

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