Cleared Traditional

STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY

K955905 · Solarcare Technologies Corp,Inc. · Chemistry
May 1996
Decision
153d
Days
Class 2
Risk

About This 510(k) Submission

K955905 is an FDA 510(k) clearance for the STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY, a Biuret (colorimetric), Total Protein (Class II — Special Controls, product code CEK), submitted by Solarcare Technologies Corp,Inc. (Bethlehem, US). The FDA issued a Cleared decision on May 30, 1996, 153 days after receiving the submission on December 29, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1635.

Submission Details

510(k) Number K955905 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 1995
Decision Date May 30, 1996
Days to Decision 153 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CEK — Biuret (colorimetric), Total Protein
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1635

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