Cleared Traditional

ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL

K955356 · Diagnostic Systems Laboratories, Inc. · Chemistry
May 1996
Decision
176d
Days
Class 1
Risk

About This 510(k) Submission

K955356 is an FDA 510(k) clearance for the ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL, a Radioimmunoassay, Estriol (Class I — General Controls, product code CGI), submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on May 15, 1996, 176 days after receiving the submission on November 21, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1265.

Submission Details

510(k) Number K955356 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 1995
Decision Date May 15, 1996
Days to Decision 176 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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