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510(k) K091454

PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM by Medtox Diagnostics, Inc. — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2009
Date Received
May 18, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Opiates
Device Class
Class II
Regulation Number
862.3650
Review Panel
TX
Submission Type

Other clearances by Medtox Diagnostics, Inc.

  • K252684 — Labcorp Fentanyl Urine Visual Test (January 29, 2026)
  • K100951 — MEDTOX BUPRENORPHINE TEST (October 18, 2010)
  • K100023 — PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM (April 5, 2010)
  • K080635 — MEDTOXSCAN (February 13, 2009)
  • K060351 — MEDTOX OXYCODONE (May 12, 2006)
  • K050394 — SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMINE/MDMA, METHADON (October 25, 2005)
  • K033334 — PROFILE -ER (November 10, 2003)
  • K031032 — VERDICT II, PROFILE II (July 14, 2003)
  • K022141 — VERDICT-II (July 30, 2002)
  • K020787 — VERDICT-II PROPOXYPHENE (May 2, 2002)

Other clearances for product code DJG

  • K252684 — Labcorp Fentanyl Urine Visual Test (January 29, 2026)
  • K250741 — Evidence MultiSTAT DOA Urine MultiPlex (January 23, 2026)
  • K253082 — LZI Buprenorphine II Enzyme Immunoassay (January 16, 2026)
  • K252520 — SEFRIA™ Hydrocodone Oral Fluid (September 11, 2025)
  • K251972 — Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative (August 15, 2025)
  • K251634 — LZI Fentanyl III Enzyme Immunoassay (June 18, 2025)
  • K240124 — BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader (June 14, 2024)
  • K240698 — Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard (May 10, 2024)
  • K231904 — Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard (March 8, 2024)
  • K232228 — Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug (February 23, 2024)