Cleared Traditional

MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer

K162698 · Shenzhen New Industries Biomedical Engineering Co., Ltd. · Chemistry
Jul 2017
Decision
290d
Days
Class 2
Risk

About This 510(k) Submission

K162698 is an FDA 510(k) clearance for the MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer, a Radioimmunoassay, Thyroid-stimulating Hormone (Class II — Special Controls, product code JLW), submitted by Shenzhen New Industries Biomedical Engineering Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on July 14, 2017, 290 days after receiving the submission on September 27, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1690.

Submission Details

510(k) Number K162698 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2016
Decision Date July 14, 2017
Days to Decision 290 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JLW — Radioimmunoassay, Thyroid-stimulating Hormone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1690

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