CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3— 510(k) K864456

Name: FDA 510(k) clearance K864456
Creator: U.S. Food and Drug Administration
Published: 1987-05-06

Substantially Equivalent

Cala Diagnostics

FDA 510(k) clearance K864456 for CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3, Substantially Equivalent on 1987-05-06. Applicant: Cala Diagnostics. Device class: 1.

Clearance details

Applicant: Cala Diagnostics
Product code: Code LAS
Device class: Class 1
Regulation: 21 CFR 862.3280
Advisory panel: Clinical Toxicology
Date received: 1986-11-13
Decision date: 1987-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Osos, CA, US

Download summary PDF View on FDA.gov ↗

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