Cleared Traditional

AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL

K920576 · Eastman Kodak Company · Chemistry
Mar 1992
Decision
42d
Days
Class 1
Risk

About This 510(k) Submission

K920576 is an FDA 510(k) clearance for the AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL, a Radioimmunoassay, Estriol (Class I — General Controls, product code CGI), submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on March 23, 1992, 42 days after receiving the submission on February 10, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1265.

Submission Details

510(k) Number K920576 FDA.gov
FDA Decision Cleared SESE
Date Received February 10, 1992
Decision Date March 23, 1992
Days to Decision 42 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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