Cleared Traditional

ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA

K962875 · Diagnostic Systems Laboratories, Inc. · Chemistry
Aug 1996
Decision
30d
Days
Class 1
Risk

About This 510(k) Submission

K962875 is an FDA 510(k) clearance for the ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA, 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 August 23, 1996, 30 days after receiving the submission on July 24, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1265.

Submission Details

510(k) Number K962875 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 1996
Decision Date August 23, 1996
Days to Decision 30 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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