Cleared Traditional

K991466 - EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE)
(FDA 510(k) Clearance)

K991466 · Selfcare, Inc. · Chemistry

May 1999

Decision

28d

Days

Class 1

Risk

K991466 is an FDA 510(k) clearance for the EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE). This device is classified as a Radioimmunoassay, Luteinizing Hormone (Class I — General Controls, product code CEP).

Submitted by Selfcare, Inc. (Waltham, US). The FDA issued a Cleared decision on May 25, 1999, 28 days after receiving the submission on April 27, 1999.

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

Submission Details

510(k) Number	K991466 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 27, 1999
Decision Date	May 25, 1999
Days to Decision	28 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF