MODIFIED MODEL 535(TM) LUMINOMETER— 510(k) K896117

Name: FDA 510(k) clearance K896117
Creator: U.S. Food and Drug Administration
Published: 1989-11-30

Substantially Equivalent

Los Alamos Diagnostics

FDA 510(k) clearance K896117 for MODIFIED MODEL 535(TM) LUMINOMETER, Substantially Equivalent on 1989-11-30. 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: 1989-10-20
Decision date: 1989-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Alamos, NM, US

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