Cleared Traditional

STC DIAGNOSTICS BENZOYLECGONINE EIA

K915785 · Solarcare Technologies Corp,Inc. · Chemistry
Mar 1992
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K915785 is an FDA 510(k) clearance for the STC DIAGNOSTICS BENZOYLECGONINE 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 March 11, 1992, 78 days after receiving the submission on December 24, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number K915785 FDA.gov
FDA Decision Cleared SESE
Date Received December 24, 1991
Decision Date March 11, 1992
Days to Decision 78 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

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