Cleared Traditional

VIDAS PROESTERONE (PRG) (30 409)

K965084 · bioMerieux, Inc. · Chemistry
Jan 1997
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K965084 is an FDA 510(k) clearance for the VIDAS PROESTERONE (PRG) (30 409), a Radioimmunoassay, Progesterone (Class I — General Controls, product code JLS), submitted by bioMerieux, Inc. (Rockland, US). The FDA issued a Cleared decision on January 9, 1997, 21 days after receiving the submission on December 19, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1620.

Submission Details

510(k) Number K965084 FDA.gov
FDA Decision Cleared SESE
Date Received December 19, 1996
Decision Date January 09, 1997
Days to Decision 21 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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