Cleared Traditional

MAGLUMI 2000 FT4

K182423 · Shenzhen New Industries Biomedical Engineering Co., Ltd. · Chemistry

Oct 2018

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K182423 is an FDA 510(k) clearance for the MAGLUMI 2000 FT4, a Radioimmunoassay, Free Thyroxine (Class II — Special Controls, product code CEC), submitted by Shenzhen New Industries Biomedical Engineering Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 4, 2018, 28 days after receiving the submission on September 6, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1695.

Submission Details

510(k) Number	K182423 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 06, 2018
Decision Date	October 04, 2018
Days to Decision	28 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF