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510(k) K010177

VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY by Sun Biomedical Laboratories, Inc. — Product Code DKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2001
Date Received
January 18, 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 Sun Biomedical Laboratories, Inc.

  • K023856 — VISUALINE METHADONE DIPSTRIPTEST (August 25, 2003)
  • K023648 — VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DETERMINATION OF COCAIN (May 6, 2003)
  • K014089 — VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATES (April 25, 2002)
  • K020136 — VISUALINE BARBITURATES DIPSTRIP TEST (March 20, 2002)
  • K011499 — VISUALINE AMPHETAMINE DIPSTRIP ASSAY (July 17, 2001)
  • K993485 — VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DETERMINATION OF COCAI (December 27, 1999)
  • K983790 — VISUALINE II (ALSO KNOWN AS SUNLINE) PHENCYCLIDINE (March 1, 1999)
  • K981314 — VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE (September 4, 1998)
  • K972032 — VISUALINE II METHAMPHETIMINE (August 12, 1997)
  • K963606 — VISUALINE COMBO V (COCAINE/THC) TEST (October 30, 1996)

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