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510(k) K010226

VERDICT -II METHAMPHETAMINE by Medtox Diagnostics, Inc. — Product Code DJC

K010226 is an FDA 510(k) premarket notification submitted by Medtox Diagnostics, Inc. for the device "VERDICT -II METHAMPHETAMINE". The FDA issued a decision of Substantially Equivalent on June 1, 2001. The device falls under product code DJC (Thin Layer Chromatography, Methamphetamine), a Class II device regulated under 21 CFR 862.3610. Medtox Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2001
Date Received
January 24, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thin Layer Chromatography, Methamphetamine
Device Class
Class II
Regulation Number
862.3610
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)
  • K091454 — PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM (July 24, 2009)
  • 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)

Other clearances for product code DJC

  • K253705 — Healgen® Accurate Oral Fluid Drug Test (March 16, 2026)
  • K240287 — LYHER® Oral fluid Multi-Drug Test Kit (Cube) (March 18, 2025)
  • K180878 — BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxaze (December 17, 2018)
  • K181305 — OralTox Oral fluid Drug Test (September 20, 2018)
  • K171403 — OralTox Oral Fluid Drug Test (February 2, 2018)
  • K161044 — AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split (July 6, 2016)
  • K132630 — WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (ME (September 27, 2013)
  • K080347 — UNISCAN -DOA SYSTEM (October 9, 2008)
  • K060355 — ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000 (August 7, 2006)
  • K060896 — MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT (June 9, 2006)

FDA data resources