Cleared Special

MODIFICATION OF CLEARPLAN EASY FERTILITY MONITOR

K990223 · Unipath , Ltd. · Chemistry

Feb 1999

Decision

30d

Days

Class 1

Risk

About This 510(k) Submission

K990223 is an FDA 510(k) clearance for the MODIFICATION OF 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 February 24, 1999, 30 days after receiving the submission on January 25, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1485.

Submission Details

510(k) Number	K990223 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 25, 1999
Decision Date	February 24, 1999
Days to Decision	30 days
Submission Type	Special
Review Panel	Chemistry (CH)
Summary	Statement