Home / 510(k) Clearances / K950369

510(k) K950369

VISUALINE II COCAINE by Sun Biomedical Laboratories, Inc. — Product Code DIO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1995
Date Received
January 31, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class
Class II
Regulation Number
862.3250
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)
  • K010177 — VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY (May 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)

Other clearances for product code DIO

  • K213211 — Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (C (January 27, 2022)
  • K211973 — DRI Cocaine Metabolite Assay (September 24, 2021)
  • K191638 — Pointe Scientific Cocaine Metabolite Enzyme Immunoassay (March 12, 2020)
  • K181499 — DRI Cocaine Metabolite Assay (July 6, 2018)
  • K170293 — Emit II Plus Cocaine Metabolite Assay (October 25, 2017)
  • K163570 — Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) (August 15, 2017)
  • K162395 — MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup (June 2, 2017)
  • K152232 — Quest Diagnostics HairCheck-DT (Cocaine) (November 18, 2016)
  • K161214 — Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test (June 27, 2016)
  • K153646 — SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Tes (March 18, 2016)