Micro EIA for Marijuana Metabolites

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K914490 ↗

FDA Product Code

LDJ

FDA applicant

Microdiagnostics, Inc.

Device Class

Class II

Regulation

21 CFR Part 862.3870

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• Micro-Strip for Phencyclidine Metabolites

  Unclassified

  FDA 510(k) K991505 Active Cleared 5 Aug 1999

• Micro Eia for Opiate Metabolites

  Class II

  FDA 510(k) K923468 Active Cleared 15 Sep 1992

• Micro-Strip for Amphetamine Metabolites

  Class II

  FDA 510(k) K974611 Active Cleared 20 Mar 1998

• Micro Eia for Amphetamine Metabolites

  Class II

  FDA 510(k) K932304 Active Cleared 7 Dec 1993

• Drugs of Abuse Multi-Test Strip

  Class II

  FDA 510(k) K011952 Active Cleared 25 Oct 2001

• Micro-Strip for Marijuana Metabolites

  Class II

  FDA 510(k) K991516 Active Cleared 5 Aug 1999

See all devices from Micro Diagnostics Corp. →

• What is the Micro EIA for Marijuana Metabolites used for?

  The Micro EIA for Marijuana Metabolites is an enzyme immunoassay device designed to detect marijuana metabolites in clinical samples as part of toxicology testing. It helps identify cannabinoids in specimens for clinical laboratory analysis.

• How is the Micro EIA for Marijuana Metabolites supplied?

  The device is supplied by Microdiagnostics, Inc. The provided data does not specify packaging details, quantities per package, or specific kit components, only that it is manufactured and distributed by this company.

• Is the Micro EIA for Marijuana Metabolites single-use or reusable?

  The provided data does not specify whether the Micro EIA for Marijuana Metabolites is designed for single-use or reusable applications. This information would typically be found in the device's instructions for use or product labeling.

• What regulatory authorization does the Micro EIA for Marijuana Metabolites have?

  The device is authorized under FDA 510(k) clearance K914490 with product code LDJ. It is classified as a Class II device and regulated under 862.3870, intended for use in clinical toxicology settings. The clearance was granted on November 29, 1991.