Cleared Traditional

ELECSYS PROGESTERONE ASSAY

K964841 · Boehringer Mannheim Corp. · Chemistry
Mar 1997
Decision
111d
Days
Class 1
Risk

About This 510(k) Submission

K964841 is an FDA 510(k) clearance for the ELECSYS PROGESTERONE ASSAY, a Radioimmunoassay, Progesterone (Class I — General Controls, product code JLS), submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on March 24, 1997, 111 days after receiving the submission on December 3, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1620.

Submission Details

510(k) Number K964841 FDA.gov
FDA Decision Cleared SESE
Date Received December 03, 1996
Decision Date March 24, 1997
Days to Decision 111 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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