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FDA 510(k)

MAGLUMI 2000 HCG/ß-HCG

K-Number: K192547 · 2020-01-17

ApplicantShenzhen New Industries Biomedical Engineering Co., Ltd.
Decision Date2020-01-17
Product CodeDHA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MAGLUMI 2000 HCG/ß-HCG 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 2020-01-17 under 510(k) number K192547. The device is classified under product code DHA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAGLUMI 2000 HCG/ß-HCG?

MAGLUMI 2000 HCG/ß-HCG is a medical device that received FDA 510(k) clearance on 2020-01-17. The listed applicant is Shenzhen New Industries Biomedical Engineering Co., Ltd.. The 510(k) number is K192547.

When did MAGLUMI 2000 HCG/ß-HCG receive FDA 510(k) clearance?

MAGLUMI 2000 HCG/ß-HCG received FDA 510(k) clearance on 2020-01-17, under 510(k) number K192547.

Who is the listed applicant for MAGLUMI 2000 HCG/ß-HCG?

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 HCG/ß-HCG?

The FDA product code for MAGLUMI 2000 HCG/ß-HCG is DHA.

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 analyzerK191499MAGLUMI 2000 25-OH Vitamin DK182423MAGLUMI 2000 FT4K162698MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer

Related Devices (Code: DHA)

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.

K233581VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackOrtho Clinical DiagnosticsK223690iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)Shenzhen Yhlo Biotech Co., Ltd.K230937Alinity i Total ß-hCG Reagent Kit, GLP systems TrackAbbott LaboratoriesK230790Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-seriesAbbott LaboratoriesK221990Access Total ßhCG (5th IS)Beckman Coulter, Inc.K212221Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay AnalyzerDiazyme Laboratories, 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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