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510(k) K942435

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

K942435 is an FDA 510(k) premarket notification submitted by Saliva Diagnostic Systems, Inc. for the device "SALIVA SAMPLER". The FDA issued a decision of Substantially Equivalent on August 21, 1995. The device falls under product code PJD (Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device), a Class II device regulated under 21 CFR 862.1675. Saliva Diagnostic Systems, Inc. has at least 2 other 510(k) clearances on record.

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.

  • K980782 — STAT-SIMPLE PYLORI (August 5, 1998)
  • K962721 — EVIDENCE PREGNANCY TEST (October 1, 1996)

Other clearances for product code PJD

  • K232898 — Quantisal™ Oral Fluid Collection Device (November 21, 2023)
  • K223781 — Quantisal™ II Oral Fluid Collection Device (July 28, 2023)
  • K200801 — Quantisal Oral Fluid Collection Device (July 28, 2020)
  • K183048 — Quantisal II Oral Fluid Collection Device (July 29, 2019)
  • K011057 — INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX (June 6, 2001)
  • K984361 — ORAL-EZE ORAL FLUID COLLECTION SYSTEM (January 13, 1999)
  • K973395 — EPISCREEN ORAL SPECIMEN COLLECTION DEVICE (February 13, 1998)
  • K970357 — EPISCREEN (March 10, 1997)

FDA data resources