CAT-3 CATECHOLAMINE ASSAY KIT— 510(k) K855214

Name: FDA 510(k) clearance K855214
Creator: U.S. Food and Drug Administration
Published: 1986-03-14

Substantially Equivalent

Whale Scientific, Inc.

FDA 510(k) clearance K855214 for CAT-3 CATECHOLAMINE ASSAY KIT, Substantially Equivalent on 1986-03-14. Applicant: Whale Scientific, Inc.. Device class: 1.

Clearance details

Applicant: Whale Scientific, Inc.
Product code: Code CHQ
Device class: Class 1
Regulation: 21 CFR 862.1165
Advisory panel: Clinical Chemistry
Date received: 1985-12-30
Decision date: 1986-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Commerce City, CO, US

Download summary PDF View on FDA.gov ↗

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