Cleared Special

K021409 - AT HOME OVULATION TEST, MODEL 9032
(FDA 510(k) Clearance)

K021409 · Phamatech, Inc. · Chemistry

May 2002

Decision

21d

Days

Class 1

Risk

K021409 is an FDA 510(k) clearance for the AT HOME OVULATION TEST, MODEL 9032, a Radioimmunoassay, Luteinizing Hormone (Class I — General Controls, product code CEP), submitted by Phamatech, Inc. (San Diego, US). The FDA issued a Cleared decision on May 24, 2002, 21 days after receiving the submission on May 3, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1485.

Submission Details

510(k) Number	K021409 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 03, 2002
Decision Date	May 24, 2002
Days to Decision	21 days
Submission Type	Special
Review Panel	Chemistry (CH)
Summary	Summary PDF