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510(k) K011952

DRUGS OF ABUSE MULTI-TEST STRIP by Microdiagnostics, Inc. — Product Code DKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2001
Date Received
June 21, 2001
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 Microdiagnostics, Inc.

  • K991505 — MICRO-STRIP FOR PHENCYCLIDINE METABOLITES (August 5, 1999)
  • K991516 — MICRO-STRIP FOR MARIJUANA METABOLITES (August 5, 1999)
  • K981388 — MICRO-STRIP FOR COCAINE METABOLITES (May 29, 1998)
  • K974611 — MICRO-STRIP FOR AMPHETAMINE METABOLITES (March 20, 1998)
  • K973761 — MICRO-STRIP FOR OPIATE METABOLITES (December 24, 1997)
  • K932304 — MICRO EIA FOR AMPHETAMINE METABOLITES (December 7, 1993)
  • K923468 — MICRO EIA FOR OPIATE METABOLITES (September 15, 1992)
  • K914533 — MICRO EIA FOR COCAINE METABOLITES (December 10, 1991)
  • K914490 — MICRO EIA FOR MARIJUANA METABOLITES (November 29, 1991)

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