Cleared Traditional

CENTRIFICHEM SYSTEM 400

K801167 · Union Carbide Corp. · Chemistry
Jun 1980
Decision
25d
Days
Class 1
Risk

About This 510(k) Submission

K801167 is an FDA 510(k) clearance for the CENTRIFICHEM SYSTEM 400, a Calculator/data Processing Module, For Clinical Use (Class I — General Controls, product code JQP), submitted by Union Carbide Corp. (Mchenry, US). The FDA issued a Cleared decision on June 9, 1980, 25 days after receiving the submission on May 15, 1980. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2100.

Submission Details

510(k) Number K801167 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 1980
Decision Date June 09, 1980
Days to Decision 25 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JQP — Calculator/data Processing Module, For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2100

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