LUMATAG T4 CHEMILUMINESCENCE ASSAY— 510(k) K911985

Name: FDA 510(k) clearance K911985
Creator: U.S. Food and Drug Administration
Published: 1991-08-02

Substantially Equivalent

London Diagnostics, Inc.

FDA 510(k) clearance K911985 for LUMATAG T4 CHEMILUMINESCENCE ASSAY, Substantially Equivalent on 1991-08-02. Applicant: London Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: London Diagnostics, Inc.
Product code: Code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1991-05-06
Decision date: 1991-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

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