Cleared Traditional

CLEARPLAN EASY FERTILITY MONITOR

K981207 · Unipath , Ltd. · Chemistry
Oct 1998
Decision
209d
Days
Class 1
Risk

About This 510(k) Submission

K981207 is an FDA 510(k) clearance for the CLEARPLAN EASY FERTILITY MONITOR, a Test, Luteinizing Hormone (lh), Over The Counter (Class I — General Controls, product code NGE), submitted by Unipath , Ltd. (Bedford, GB). The FDA issued a Cleared decision on October 28, 1998, 209 days after receiving the submission on April 2, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1485.

Submission Details

510(k) Number K981207 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 1998
Decision Date October 28, 1998
Days to Decision 209 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code NGE — Test, Luteinizing Hormone (lh), Over The Counter
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1485