Cleared Special

K002867 - INVERNESS MEDICAL OVULATION PREDICTOR TEST
(FDA 510(k) Clearance)

K002867 · Selfcare, Inc. · Chemistry

Oct 2000

Decision

29d

Days

Class 1

Risk

K002867 is an FDA 510(k) clearance for the INVERNESS MEDICAL OVULATION PREDICTOR TEST, a Radioimmunoassay, Luteinizing Hormone (Class I — General Controls, product code CEP), submitted by Selfcare, Inc. (Waltham, US). The FDA issued a Cleared decision on October 12, 2000, 29 days after receiving the submission on September 13, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1485.

Submission Details

510(k) Number	K002867 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 13, 2000
Decision Date	October 12, 2000
Days to Decision	29 days
Submission Type	Special
Review Panel	Chemistry (CH)
Summary	Summary PDF