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510(k) K970357

EPISCREEN by Epitope, Inc. — Product Code PJD

K970357 is an FDA 510(k) premarket notification submitted by Epitope, Inc. for the device "EPISCREEN". The FDA issued a decision of Substantially Equivalent on March 10, 1997. 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. Epitope, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1997
Date Received
January 30, 1997
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 Epitope, Inc.

  • K973395 — EPISCREEN ORAL SPECIMEN COLLECTION DEVICE (February 13, 1998)

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)
  • K942435 — SALIVA SAMPLER (August 21, 1995)

FDA data resources