Saliva Sampler

FDA 510(k) K942435 · Saliva Diagnostic Systems, Inc.

Substantially Equivalent

510(k) numberK942435

Submission

Device name
Saliva Sampler
Applicant
Saliva Diagnostic Systems, Inc.
Vancouver, WA, US
Received
May 20, 1994
Decision date
August 21, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
PJD – Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1675
Specialty
Clinical Chemistry

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

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K232898Quantisal™ Oral Fluid Collection DevicePJD · Traditional Immunalysis Corporation11/21/2023SE
K223781Quantisal™ II Oral Fluid Collection DevicePJD · Traditional Immunalysis Corporation07/28/2023SE
K200801Quantisal Oral Fluid Collection DevicePJD · Traditional Immunalysis Corporation07/28/2020SE
K183048Quantisal II Oral Fluid Collection DevicePJD · Traditional Immunalysis Corporation07/29/2019SE
K011057Intercept Oral Fluid Drug Test Oral Specimen Collection Device, Model 503-XXXXPJD · Traditional OraSure Technologies, Inc.06/06/2001SE
K984361Oral-Eze Oral Fluid Collection SystemPJD · Traditional Osborn Laboratories, Inc.01/13/1999SE
K973395Episcreen Oral Specimen Collection DevicePJD · Traditional Epitope, Inc.02/13/1998SE
K970357EpiscreenPJD · Traditional Epitope, Inc.03/10/1997SE

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Questions and answers

When was Saliva Sampler cleared by the FDA?

Saliva Sampler (K942435) received a 510(k) decision of Substantially Equivalent on August 21, 1995, 458 days after the submission was received.

What is the product code of K942435?

The FDA product code is PJD – Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device, a Class II (moderate risk) device regulated under 21 CFR 862.1675.