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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 the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen New Industries Biomedical Engineering Co., Ltd.. It received FDA 510(k) clearance on 2018-10-04 under 510(k) 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. The listed applicant is Shenzhen New Industries Biomedical Engineering Co., Ltd.. The 510(k) number is K182423.

When did MAGLUMI 2000 FT4 receive FDA 510(k) clearance?

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

Who is the listed applicant for MAGLUMI 2000 FT4?

The FDA 510(k) record lists Shenzhen New Industries Biomedical Engineering Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAGLUMI 2000 FT4?

The FDA product code for MAGLUMI 2000 FT4 is CEC.

Other records listing Shenzhen New Industries Biomedical Engineering Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232587MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzerK192547MAGLUMI 2000 HCG/ß-HCGK191499MAGLUMI 2000 25-OH Vitamin DK162698MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer

Related Devices (Code: CEC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240273Access Free T4Beckman Coulter, Inc.K220456Elecsys FT4 IVRoche DiagnosticsK181233Elecsys FT4 IIIRoche DiagnosticsK173122Abbott Architect Free T4Abbott LaboratoriesK152422FREND™ Free T4 Test SystemNanoentek USA, 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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