Cleared Traditional

STC DIAGNOSTICS AUTO0LYTE COCAINE METABOLITE EIA

K921140 · Solarcare Technologies Corp,Inc. · Toxicology
Aug 1992
Decision
163d
Days
Class 2
Risk

About This 510(k) Submission

K921140 is an FDA 510(k) clearance for the STC DIAGNOSTICS AUTO0LYTE COCAINE METABOLITE EIA, a Enzyme Immunoassay, Cocaine (Class II — Special Controls, product code JXO), submitted by Solarcare Technologies Corp,Inc. (Bethlehem, US). The FDA issued a Cleared decision on August 20, 1992, 163 days after receiving the submission on March 10, 1992. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number K921140 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 1992
Decision Date August 20, 1992
Days to Decision 163 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code JXO — Enzyme Immunoassay, Cocaine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3250