STC DIAGNOSTICS AUTO-LYTE CREATININE ASSAY— 510(k) K954266

Name: FDA 510(k) clearance K954266
Creator: U.S. Food and Drug Administration
Published: 1995-10-13

Substantially Equivalent

Solarcare Technologies Corp,Inc.

FDA 510(k) clearance K954266 for STC DIAGNOSTICS AUTO-LYTE CREATININE ASSAY, Substantially Equivalent on 1995-10-13. Applicant: Solarcare Technologies Corp,Inc.. Device class: 2.

Clearance details

Applicant: Solarcare Technologies Corp,Inc.
Product code: Code CGX
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 1995-09-12
Decision date: 1995-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, PA, US

Download summary PDF View on FDA.gov ↗

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