Cleared Traditional

K860828 - FORETEL, COLOR OVULATION TEST
(FDA 510(k) Clearance)

K860828 · Nms Pharmaceuticals, Inc. · Chemistry

Aug 1986

Decision

152d

Days

Class 1

Risk

K860828 is an FDA 510(k) clearance for the FORETEL, COLOR OVULATION TEST. This device is classified as a Radioimmunoassay, Luteinizing Hormone (Class I — General Controls, product code CEP).

Submitted by Nms Pharmaceuticals, Inc. (Newport Beach, US). The FDA issued a Cleared decision on August 4, 1986, 152 days after receiving the submission on March 5, 1986.

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

Submission Details

510(k) Number	K860828 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 05, 1986
Decision Date	August 04, 1986
Days to Decision	152 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—