Cleared Traditional

CENTRIA SYSTEM 2 AUTOMATED METHOD/RIA

K801037 · Union Carbide Corp. · Chemistry
May 1980
Decision
26d
Days
Class 1
Risk

About This 510(k) Submission

K801037 is an FDA 510(k) clearance for the CENTRIA SYSTEM 2 AUTOMATED METHOD/RIA, a Automated Radioimmunoassay Systems, For Clinical Use (Class I — General Controls, product code LCI), submitted by Union Carbide Corp. (Walker, US). The FDA issued a Cleared decision on May 28, 1980, 26 days after receiving the submission on May 2, 1980. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2050.

Submission Details

510(k) Number K801037 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 1980
Decision Date May 28, 1980
Days to Decision 26 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code LCI — Automated Radioimmunoassay Systems, For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2050