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510(k) K060810

ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC by Ind Diagnostic, Inc. — Product Code DKZ

K060810 is an FDA 510(k) premarket notification submitted by Ind Diagnostic, Inc. for the device "ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC". The FDA issued a decision of Substantially Equivalent on August 7, 2006. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Ind Diagnostic, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2006
Date Received
March 24, 2006
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 Ind Diagnostic, Inc.

  • K103037 — IND URINARY TRACT INFECTION (UTI) TEST STRIPS (April 17, 2012)
  • K100031 — IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10 (July 19, 2010)
  • K063390 — URINE CHEMISTRY ANALYZER UR-50 (March 1, 2007)
  • K052694 — ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES. (December 16, 2005)
  • K052662 — ONE STEP FSH MENOPAUSAL TEST (November 30, 2005)
  • K050741 — IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT (May 16, 2005)
  • K023638 — CASSETTE/URINE HCG (January 3, 2003)

Other clearances for product code DKZ

  • K240670 — DRI Ecstasy Plus Assay (October 30, 2024)
  • K233019 — AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest (December 13, 2023)
  • K231137 — Xenta Drug Screen Cup, Xenta Drug Screen Dipcard (May 19, 2023)
  • K200363 — Quidel Triage® TOX Drug Screen, 94600 (March 11, 2020)
  • K191099 — Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel (October 3, 2019)
  • K182719 — Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro (June 19, 2019)
  • K182738 — Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Mul (March 27, 2019)
  • K180879 — BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi- (December 14, 2018)
  • K181945 — QuickScreen Pro Multi Drug Screening Test, Model 9395Z (October 18, 2018)
  • K173303 — INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT (February 23, 2018)

FDA data resources