LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY— 510(k) K912858

Name: FDA 510(k) clearance K912858
Creator: U.S. Food and Drug Administration
Published: 1991-07-30

Substantially Equivalent

London Diagnostics, Inc.

FDA 510(k) clearance K912858 for LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY, Substantially Equivalent on 1991-07-30. Applicant: London Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: London Diagnostics, Inc.
Product code: Code CFL
Device class: Class 1
Regulation: 21 CFR 862.1370
Advisory panel: Clinical Chemistry
Date received: 1991-06-28
Decision date: 1991-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

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