COBAS 6000 SERIES SYSTEM— 510(k) K060373

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K060373 for COBAS 6000 SERIES SYSTEM, Substantially Equivalent on 2006-03-13. Applicant: Roche Diagnostics.

Clearance details

Applicant: Roche Diagnostics
Product code: Code CEM
Advisory panel: Clinical Chemistry
Date received: 2006-02-13
Decision date: 2006-03-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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