Cleared Traditional

K920418 - IL TEST CANNABINOID, 35282 (FDA 510(k) Clearance)

Feb 1992
Decision
27d
Days
Class 2
Risk

K920418 is an FDA 510(k) clearance for the IL TEST CANNABINOID, 35282. This device is classified as a Enzyme Immunoassay, Cannabinoids (Class II - Special Controls, product code LDJ).

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on February 27, 1992, 27 days after receiving the submission on January 31, 1992.

This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3870.

Submission Details

510(k) Number K920418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1992
Decision Date February 27, 1992
Days to Decision 27 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LDJ — Enzyme Immunoassay, Cannabinoids
Device Class Class II - Special Controls
CFR Regulation 21 CFR 862.3870

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