STC DIAGNOSTICS AUTO-LYTE(TM) ETHYL ALCOHOL ASSAY— 510(k) K931516

Name: FDA 510(k) clearance K931516
Creator: U.S. Food and Drug Administration
Published: 1993-07-19

Substantially Equivalent

Solarcare Technologies Corp,Inc.

FDA 510(k) clearance K931516 for STC DIAGNOSTICS AUTO-LYTE(TM) ETHYL ALCOHOL ASSAY, Substantially Equivalent on 1993-07-19. Applicant: Solarcare Technologies Corp,Inc.. Device class: 2.

Clearance details

Applicant: Solarcare Technologies Corp,Inc.
Product code: Code DIC
Device class: Class 2
Regulation: 21 CFR 862.3040
Advisory panel: Clinical Toxicology
Date received: 1993-03-26
Decision date: 1993-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, PA, US

Download summary PDF View on FDA.gov ↗

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