Cleared Traditional

OPUS PROGESTERONE

K971725 · Behring Diagnostics, Inc. · Chemistry
Jun 1997
Decision
40d
Days
Class 1
Risk

About This 510(k) Submission

K971725 is an FDA 510(k) clearance for the OPUS PROGESTERONE, a Radioimmunoassay, Progesterone (Class I — General Controls, product code JLS), submitted by Behring Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on June 18, 1997, 40 days after receiving the submission on May 9, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1620.

Submission Details

510(k) Number K971725 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 1997
Decision Date June 18, 1997
Days to Decision 40 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JLS — Radioimmunoassay, Progesterone
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1620

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