Cleared Traditional

ELECSYS ESTRADIOL ASSAY

K965109 · Boehringer Mannheim Corp. · Chemistry
Feb 1997
Decision
60d
Days
Class 1
Risk

About This 510(k) Submission

K965109 is an FDA 510(k) clearance for the ELECSYS ESTRADIOL ASSAY, a Radioimmunoassay, Estradiol (Class I — General Controls, product code CHP), submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on February 18, 1997, 60 days after receiving the submission on December 20, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1260.

Submission Details

510(k) Number K965109 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 1996
Decision Date February 18, 1997
Days to Decision 60 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CHP — Radioimmunoassay, Estradiol
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1260

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