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510(k) K935052

MICROLINE SCREEN FOR AMPHETAMINE by Drug Screening Systems, Inc. — Product Code DKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1994
Date Received
October 20, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Amphetamine
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type

Other clearances by Drug Screening Systems, Inc.

  • K945829 — MICROLINE SCREEN FOR BENZODIAZEPINE (January 25, 1995)
  • 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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