Cleared Traditional

COBAS FARA II CENTRIFUGAL ANALYZER

K893854 · Roche Diagnostic Systems, Inc. · Chemistry
Aug 1989
Decision
70d
Days
Class 1
Risk

About This 510(k) Submission

K893854 is an FDA 510(k) clearance for the COBAS FARA II CENTRIFUGAL ANALYZER, 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 August 3, 1989, 70 days after receiving the submission on May 25, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2140.

Submission Details

510(k) Number K893854 FDA.gov
FDA Decision Cleared SESE
Date Received May 25, 1989
Decision Date August 03, 1989
Days to Decision 70 days
Submission Type Traditional
Review Panel Chemistry (CH)
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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