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510(k) K973154

UBI MAGIWEL MARIJUANA METABOLITES by United Biotech, Inc. — Product Code LDJ

K973154 is an FDA 510(k) premarket notification submitted by United Biotech, Inc. for the device "UBI MAGIWEL MARIJUANA METABOLITES". The FDA issued a decision of Substantially Equivalent on July 22, 1998. The device falls under product code LDJ (Enzyme Immunoassay, Cannabinoids), a Class II device regulated under 21 CFR 862.3870. United Biotech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1998
Date Received
August 22, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Cannabinoids
Device Class
Class II
Regulation Number
862.3870
Review Panel
TX
Submission Type

Other clearances by United Biotech, Inc.

  • K981573 — UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE (September 15, 1998)
  • K973692 — UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE (February 9, 1998)
  • K973153 — UBI MAGIWEL AMPHETAMINE METABOLITES (October 28, 1997)
  • K973156 — UBI MAGIWEL COCAINE METABOLITES (October 28, 1997)
  • K973155 — UBI MAGIWEL OPIATE METABOLITES (October 28, 1997)
  • K962211 — UBI MAGIWEL THYROXINE (T4) QUANTITATIVE (July 8, 1996)
  • K961236 — UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVE (May 30, 1996)
  • K951993 — UBI MAGIWEL FERRITIN QUANTITATIVE (July 5, 1995)
  • K924689 — UBI MAGIWEL(TM) HELICOBACTER PYLORI IGG (August 10, 1993)
  • K905473 — UBI MAGIWEL CORTISOL QUANTITATIVE (January 31, 1991)

Other clearances for product code LDJ

  • K232732 — Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapi (January 17, 2024)
  • K232604 — LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test (January 10, 2024)
  • K223162 — Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test C (March 17, 2023)
  • K192515 — BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY (October 11, 2019)
  • K153741 — CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test (March 18, 2016)
  • K152643 — EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Te (November 2, 2015)
  • K151203 — Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibr (June 5, 2015)
  • K141320 — LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Cali (May 28, 2015)
  • K142408 — FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep (September 25, 2014)
  • K140546 — HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST (June 6, 2014)

FDA data resources