Cleared Traditional

STC DIAGNOSTICS AUTO-LYTE PH ASSAY

K954158 · Solarcare Technologies Corp,Inc. · Chemistry
Apr 1996
Decision
238d
Days
Class 1
Risk

About This 510(k) Submission

K954158 is an FDA 510(k) clearance for the STC DIAGNOSTICS AUTO-LYTE PH ASSAY, a Automated Urinalysis System (Class I — General Controls, product code KQO), submitted by Solarcare Technologies Corp,Inc. (Bethlehem, US). The FDA issued a Cleared decision on April 30, 1996, 238 days after receiving the submission on September 5, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2900.

Submission Details

510(k) Number K954158 FDA.gov
FDA Decision Cleared SESE
Date Received September 05, 1995
Decision Date April 30, 1996
Days to Decision 238 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code KQO — Automated Urinalysis System
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2900

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