LIGHTCYCLER INSTRUMENT VERSION 1.2— 510(k) K033734

Name: FDA 510(k) clearance K033734
Creator: U.S. Food and Drug Administration
Published: 2003-12-17

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K033734 for LIGHTCYCLER INSTRUMENT VERSION 1.2, Substantially Equivalent on 2003-12-17. Applicant: Roche Diagnostics Corp.. Device class: 1.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code JJF
Device class: Class 1
Regulation: 21 CFR 862.2170
Advisory panel: Clinical Chemistry
Date received: 2003-11-28
Decision date: 2003-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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