MICRO-PLATE OPIATES ASSAY— 510(k) K924446

Name: FDA 510(k) clearance K924446
Creator: U.S. Food and Drug Administration
Published: 1992-10-15

Substantially Equivalent

Solarcare Technologies Corp,Inc.

FDA 510(k) clearance K924446 for MICRO-PLATE OPIATES ASSAY, Substantially Equivalent on 1992-10-15. 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: 1992-09-01
Decision date: 1992-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, PA, US

Download summary PDF View on FDA.gov ↗

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