Cleared Traditional

STC DIAGNOSTICS AUTO-LYTE(TM) ETHYL ALCOHOL ASSAY

K931516 · Solarcare Technologies Corp,Inc. · Toxicology

Jul 1993

Decision

115d

Days

Class 2

Risk

About This 510(k) Submission

K931516 is an FDA 510(k) clearance for the STC DIAGNOSTICS AUTO-LYTE(TM) ETHYL ALCOHOL ASSAY, a Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method (Class II — Special Controls, product code DIC), submitted by Solarcare Technologies Corp,Inc. (Bethlehem, US). The FDA issued a Cleared decision on July 19, 1993, 115 days after receiving the submission on March 26, 1993. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3040.

Submission Details

510(k) Number	K931516 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 26, 1993
Decision Date	July 19, 1993
Days to Decision	115 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Statement

Device Classification

Product Code	DIC — Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.3040