STC DIAGNOSTICS AUTO-LYTE URINARY HEMOGLOBIN ASSAY— 510(k) K954326

Name: FDA 510(k) clearance K954326
Creator: U.S. Food and Drug Administration
Published: 1996-07-23

Substantially Equivalent

Solarcare Technologies Corp,Inc.

FDA 510(k) clearance K954326 for STC DIAGNOSTICS AUTO-LYTE URINARY HEMOGLOBIN ASSAY, Substantially Equivalent on 1996-07-23. Applicant: Solarcare Technologies Corp,Inc.. Device class: 2.

Clearance details

Applicant: Solarcare Technologies Corp,Inc.
Product code: Code JIT
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1995-09-15
Decision date: 1996-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, PA, US

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