Cleared Traditional

CENTRIFI CHEM SYSTEM 400 ANALYZER

K810596 · Union Carbide Corp. · Chemistry
Mar 1981
Decision
11d
Days
Class 1
Risk

About This 510(k) Submission

K810596 is an FDA 510(k) clearance for the CENTRIFI CHEM SYSTEM 400 ANALYZER, 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 March 17, 1981, 11 days after receiving the submission on March 6, 1981. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2160.

Submission Details

510(k) Number K810596 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 1981
Decision Date March 17, 1981
Days to Decision 11 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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