Cleared Traditional

K851445 - COLOR OVULATION TEST
(FDA 510(k) Clearance)

K851445 · Nms Pharmaceuticals, Inc. · Chemistry device

Jul 1985

Decision

109d

Days

Class 1

Risk

K851445 is an FDA 510(k) clearance for the 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 July 29, 1985, 109 days after receiving the submission on April 11, 1985.

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

Submission Details

510(k) Number	K851445 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 11, 1985
Decision Date	July 29, 1985
Days to Decision	109 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—