Cleared Traditional

ROCHE COBAS TAQMAN ANALYZER

K012966 · Roche Molecular Systems, Inc. · Chemistry
Feb 2002
Decision
150d
Days
Class 1
Risk

About This 510(k) Submission

K012966 is an FDA 510(k) clearance for the ROCHE COBAS TAQMAN ANALYZER, a Analyzer, Chemistry, Micro, For Clinical Use (Class I — General Controls, product code JJF), submitted by Roche Molecular Systems, Inc. (Pleasanton, US). The FDA issued a Cleared decision on February 1, 2002, 150 days after receiving the submission on September 4, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2170.

Submission Details

510(k) Number K012966 FDA.gov
FDA Decision Cleared SESE
Date Received September 04, 2001
Decision Date February 01, 2002
Days to Decision 150 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJF — Analyzer, Chemistry, Micro, For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2170

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