Cleared Traditional

STC DIAGNOSTICS AUTO-LYTE URINARY HEMOGLOBIN ASSAY

K954326 · Solarcare Technologies Corp,Inc. · Chemistry
Jul 1996
Decision
312d
Days
Class 2
Risk

About This 510(k) Submission

K954326 is an FDA 510(k) clearance for the STC DIAGNOSTICS AUTO-LYTE URINARY HEMOGLOBIN ASSAY, a Calibrator, Secondary (Class II — Special Controls, product code JIT), submitted by Solarcare Technologies Corp,Inc. (Bethlehem, US). The FDA issued a Cleared decision on July 23, 1996, 312 days after receiving the submission on September 15, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K954326 FDA.gov
FDA Decision Cleared SESE
Date Received September 15, 1995
Decision Date July 23, 1996
Days to Decision 312 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JIT — Calibrator, Secondary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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