STC DIAGNOSTICS AUTO-LYTE OPIATE EIA— 510(k) K921328

Name: FDA 510(k) clearance K921328
Creator: U.S. Food and Drug Administration
Published: 1992-08-20

Substantially Equivalent

Solarcare Technologies Corp,Inc.

FDA 510(k) clearance K921328 for STC DIAGNOSTICS AUTO-LYTE OPIATE EIA, Substantially Equivalent on 1992-08-20. Applicant: Solarcare Technologies Corp,Inc.. Device class: 2.

Clearance details

Applicant: Solarcare Technologies Corp,Inc.
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 1992-03-18
Decision date: 1992-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, PA, US

Download summary PDF View on FDA.gov ↗

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