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510(k) K905491

MICROLINE SCREEN FOR OPIATES by Drug Screening Systems, Inc. — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1991
Date Received
December 7, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Opiates
Device Class
Class II
Regulation Number
862.3650
Review Panel
TX
Submission Type

Other clearances by Drug Screening Systems, Inc.

  • K945829 — MICROLINE SCREEN FOR BENZODIAZEPINE (January 25, 1995)
  • K935052 — MICROLINE SCREEN FOR AMPHETAMINE (September 16, 1994)
  • K933480 — MICROLINE SCREEN FOR BARBITURATES (October 29, 1993)
  • K921651 — MICROLINE SCREEN FOR PHENCYCLIDINE (July 8, 1992)
  • K914915 — MICROLINE SCREEN FOR CANNABINOID (January 22, 1992)
  • K911652 — MIRCOLINE SCREEN FOR COCAINE (May 15, 1991)
  • K910525 — MICROLINE SCREEN FOR METHAMPHETAMINE (April 5, 1991)

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