Cleared Traditional

STC DIAGNOSTICS AUTO-LYTE CREATININE ASSAY

K954266 · Solarcare Technologies Corp,Inc. · Chemistry
Oct 1995
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K954266 is an FDA 510(k) clearance for the STC DIAGNOSTICS AUTO-LYTE CREATININE ASSAY, a Alkaline Picrate, Colorimetry, Creatinine (Class II — Special Controls, product code CGX), submitted by Solarcare Technologies Corp,Inc. (Bethlehem, US). The FDA issued a Cleared decision on October 13, 1995, 31 days after receiving the submission on September 12, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K954266 FDA.gov
FDA Decision Cleared SESE
Date Received September 12, 1995
Decision Date October 13, 1995
Days to Decision 31 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CGX — Alkaline Picrate, Colorimetry, Creatinine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1225

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