Cleared Special

COBAS 8000 MODULAR SERIES ANALYZER

K100853 · Roche Diagnostics Corp. · Chemistry
Sep 2010
Decision
167d
Days
Class 2
Risk

About This 510(k) Submission

K100853 is an FDA 510(k) clearance for the COBAS 8000 MODULAR SERIES ANALYZER, a Albumin, Antigen, Antiserum, Control (Class II — Special Controls, product code DCF), submitted by Roche Diagnostics Corp. (Indianapolos, US). The FDA issued a Cleared decision on September 9, 2010, 167 days after receiving the submission on March 26, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5040.

Submission Details

510(k) Number K100853 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 2010
Decision Date September 09, 2010
Days to Decision 167 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DCF — Albumin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5040

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