COBAS LITHIUM— 510(k) K063684

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K063684 for COBAS LITHIUM, Substantially Equivalent on 2008-03-21. Applicant: Roche Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code NDW
Device class: Class 2
Regulation: 21 CFR 862.3560
Advisory panel: Clinical Toxicology
Date received: 2006-12-12
Decision date: 2008-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.