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510(k) K945829

MICROLINE SCREEN FOR BENZODIAZEPINE by Drug Screening Systems, Inc. — Product Code JXM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 1995
Date Received
November 29, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Benzodiazepine
Device Class
Class II
Regulation Number
862.3170
Review Panel
TX
Submission Type

Other clearances by Drug Screening Systems, Inc.

  • 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)
  • K905491 — MICROLINE SCREEN FOR OPIATES (March 13, 1991)

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  • K190968 — CEDIA Benzodiazepine Assay (December 9, 2019)
  • K173963 — DRI Benzodiazepine Assay (February 21, 2018)
  • K163590 — Psychemedics Microplate EIA for Benzodiazepines in Hair (September 15, 2017)
  • K163704 — Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card (August 2, 2017)
  • K153597 — Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card (May 23, 2016)
  • K151771 — Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Cal (January 5, 2016)
  • K151642 — Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card (August 13, 2015)
  • K150356 — Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card (May 13, 2015)