Cleared Traditional

CUE FERTILITY MONITOR

K850579 · Zetek, Inc. · Toxicology

Mar 1985

Decision

37d

Days

Class 1

Risk

About This 510(k) Submission

K850579 is an FDA 510(k) clearance for the CUE FERTILITY MONITOR, a Test, Luteinizing Hormone (lh), Over The Counter (Class I — General Controls, product code NGE), submitted by Zetek, Inc. (Chicago, US). The FDA issued a Cleared decision on March 22, 1985, 37 days after receiving the submission on February 13, 1985. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1485.

Submission Details

510(k) Number	K850579 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 13, 1985
Decision Date	March 22, 1985
Days to Decision	37 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	—