Cleared Traditional

UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)

K974721 · Bayer Corp. · Chemistry
Mar 1998
Decision
75d
Days
Class 1
Risk

About This 510(k) Submission

K974721 is an FDA 510(k) clearance for the UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM), a Radioimmunoassay, Estriol (Class I — General Controls, product code CGI), submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on March 3, 1998, 75 days after receiving the submission on December 18, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1265.

Submission Details

510(k) Number K974721 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 1997
Decision Date March 03, 1998
Days to Decision 75 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

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

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