Cleared Traditional

COBAS ALPHA

K910222 · Roche Diagnostic Systems, Inc. · Toxicology
Feb 1991
Decision
40d
Days
Class 1
Risk

About This 510(k) Submission

K910222 is an FDA 510(k) clearance for the COBAS ALPHA, a Analyzer, Chemistry, Centrifugal, For Clinical Use (Class I — General Controls, product code JJG), submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on February 27, 1991, 40 days after receiving the submission on January 18, 1991. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.2140.

Submission Details

510(k) Number K910222 FDA.gov
FDA Decision Cleared SESE
Date Received January 18, 1991
Decision Date February 27, 1991
Days to Decision 40 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code JJG — Analyzer, Chemistry, Centrifugal, For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2140

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