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

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..

Clearance details

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

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.