Cleared Traditional

CENTRIFICHEM SYSTEM 500

K810129 · Union Carbide Corp. · Chemistry
Feb 1981
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K810129 is an FDA 510(k) clearance for the CENTRIFICHEM SYSTEM 500, a Analyzer, Chemistry (photometric, Discrete), For Clinical Use (Class I — General Controls, product code JJE), submitted by Union Carbide Corp. (Mchenry, US). The FDA issued a Cleared decision on February 2, 1981, 14 days after receiving the submission on January 19, 1981. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2160.

Submission Details

510(k) Number K810129 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 1981
Decision Date February 02, 1981
Days to Decision 14 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JJE — Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2160

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