Cleared Traditional

MICROPLATE CANNABINOIDS ASSAY

K924815 · Solarcare Technologies Corp,Inc. · Toxicology
Jan 1993
Decision
123d
Days
Class 2
Risk

About This 510(k) Submission

K924815 is an FDA 510(k) clearance for the MICROPLATE CANNABINOIDS ASSAY, a Enzyme Immunoassay, Cannabinoids (Class II — Special Controls, product code LDJ), submitted by Solarcare Technologies Corp,Inc. (Bethlehem, US). The FDA issued a Cleared decision on January 26, 1993, 123 days after receiving the submission on September 25, 1992. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3870.

Submission Details

510(k) Number K924815 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 1992
Decision Date January 26, 1993
Days to Decision 123 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

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

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