Cleared Traditional

K013323 - TCI-31 LIFELONG OVULATION TESTER
(FDA 510(k) Clearance)

K013323 · Tci New York · Chemistry

Dec 2001

Decision

61d

Days

Class 1

Risk

K013323 is an FDA 510(k) clearance for the TCI-31 LIFELONG OVULATION TESTER, a Radioimmunoassay, Luteinizing Hormone (Class I — General Controls, product code CEP), submitted by Tci New York (Los Angeles, US). The FDA issued a Cleared decision on December 5, 2001, 61 days after receiving the submission on October 5, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1485.

Submission Details

510(k) Number	K013323 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 05, 2001
Decision Date	December 05, 2001
Days to Decision	61 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF