LAD MODEL 535 LUMINOMETER— 510(k) K864201

Name: FDA 510(k) clearance K864201
Creator: U.S. Food and Drug Administration
Published: 1987-01-13

Substantially Equivalent

Los Alamos Diagnostics

FDA 510(k) clearance K864201 for LAD MODEL 535 LUMINOMETER, Substantially Equivalent on 1987-01-13. Applicant: Los Alamos Diagnostics. Device class: 1.

Clearance details

Applicant: Los Alamos Diagnostics
Product code: Code JJQ
Device class: Class 1
Regulation: 21 CFR 862.2300
Advisory panel: Clinical Chemistry
Date received: 1986-10-27
Decision date: 1987-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Alamos, NM, US

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