Cleared Traditional

COAT-A-COUNT FREE ESTRIOL

K932989 · Diagnostic Products Corp. · Chemistry
Dec 1994
Decision
549d
Days
Class 1
Risk

About This 510(k) Submission

K932989 is an FDA 510(k) clearance for the COAT-A-COUNT FREE ESTRIOL, a Radioimmunoassay, Estriol (Class I — General Controls, product code CGI), submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on December 19, 1994, 549 days after receiving the submission on June 18, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1265.

Submission Details

510(k) Number K932989 FDA.gov
FDA Decision Cleared SESE
Date Received June 18, 1993
Decision Date December 19, 1994
Days to Decision 549 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

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

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