LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY— 510(k) K905814

Name: FDA 510(k) clearance K905814
Creator: U.S. Food and Drug Administration
Published: 1991-02-04

Substantially Equivalent

London Diagnostics, Inc.

FDA 510(k) clearance K905814 for LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY, Substantially Equivalent on 1991-02-04. Applicant: London Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: London Diagnostics, Inc.
Product code: Code CGJ
Device class: Class 1
Regulation: 21 CFR 862.1300
Advisory panel: Clinical Chemistry
Date received: 1990-12-28
Decision date: 1991-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

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