Cleared Traditional

K973860 - OVULON MONITOR (FDA 510(k) Clearance)

K973860 · Conception Technology, Inc. · Toxicology device

Jan 1998

Decision

90d

Days

Class 1

Risk

K973860 is an FDA 510(k) clearance for the OVULON MONITOR. This device is classified as a Test, Luteinizing Hormone (lh), Over The Counter (Class I - General Controls, product code NGE).

Submitted by Conception Technology, Inc. (Ft. Collins, US). The FDA issued a Cleared decision on January 7, 1998, 90 days after receiving the submission on October 9, 1997.

This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.1485.

Submission Details

510(k) Number	K973860 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 09, 1997
Decision Date	January 07, 1998
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Statement