Cleared Traditional

IMMUNOREACTIVE ESTRIOL RIA KIT

K802754 · Microanalytic Research, Inc. · Chemistry
Jan 1981
Decision
79d
Days
Class 1
Risk

About This 510(k) Submission

K802754 is an FDA 510(k) clearance for the IMMUNOREACTIVE ESTRIOL RIA KIT, a Radioimmunoassay, Estriol (Class I — General Controls, product code CGI), submitted by Microanalytic Research, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 21, 1981, 79 days after receiving the submission on November 3, 1980. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1265.

Submission Details

510(k) Number K802754 FDA.gov
FDA Decision Cleared SESE
Date Received November 03, 1980
Decision Date January 21, 1981
Days to Decision 79 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CGI — Radioimmunoassay, Estriol
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1265

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