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FDA 510(k)

MAGLUMI 2000 FT4

K-Number: K182423 · 2018-10-04

ApplicantShenzhen New Industries Biomedical Engineering Co., Ltd.
Decision Date2018-10-04
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MAGLUMI 2000 FT4 is a medical device manufactured by Shenzhen New Industries Biomedical Engineering Co., Ltd.. It received FDA 510(k) clearance on 2018-10-04 under approval number K182423. The device is classified under product code CEC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAGLUMI 2000 FT4?

MAGLUMI 2000 FT4 is a medical device that received FDA 510(k) clearance on 2018-10-04. It is manufactured by Shenzhen New Industries Biomedical Engineering Co., Ltd.. The 510(k) number is K182423.

When was MAGLUMI 2000 FT4 approved by the FDA?

MAGLUMI 2000 FT4 received FDA 510(k) clearance on 2018-10-04, under approval number K182423.

What company makes MAGLUMI 2000 FT4?

MAGLUMI 2000 FT4 is manufactured by Shenzhen New Industries Biomedical Engineering Co., Ltd..

What is the FDA product code for MAGLUMI 2000 FT4?

The FDA product code for MAGLUMI 2000 FT4 is CEC.

Other Devices by Shenzhen New Industries Biomedical Engineering Co., Ltd.

K162698MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer K191499MAGLUMI 2000 25-OH Vitamin D K192547MAGLUMI 2000 HCG/ß-HCG K232587MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer

Related Devices (Code: CEC)

K152422FREND™ Free T4 Test SystemNanoentek USA, Inc. K173122Abbott Architect Free T4Abbott Laboratories K181233Elecsys FT4 IIIRoche Diagnostics K220456Elecsys FT4 IVRoche Diagnostics K240273Access Free T4Beckman Coulter, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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