COBAS C 111 ANALYZER— 510(k) K071211

Clearance details

Applicant

Roche Diagnostics

Product code

Code CIT

Device class

Class 2

Regulation

21 CFR 862.1100

Advisory panel

Clinical Chemistry

Date received

2007-05-01

Decision date

2007-07-30

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Indianapolis, IN, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K071211.