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510(k) K984361

ORAL-EZE ORAL FLUID COLLECTION SYSTEM by Osborn Laboratories, Inc. — Product Code PJD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1999
Date Received
December 7, 1998
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 Osborn Laboratories, Inc.

  • K984529 — HEMOCHEK SAMPLE COLLECTION KIT (January 28, 1999)

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  • K973395 — EPISCREEN ORAL SPECIMEN COLLECTION DEVICE (February 13, 1998)
  • K970357 — EPISCREEN (March 10, 1997)
  • K942435 — SALIVA SAMPLER (August 21, 1995)