FDA 510(k)

MAGLUMI 2000 HCG/ß-HCG

N.º K: K192547 · 2020-01-17

SolicitanteShenzhen New Industries Biomedical Engineering Co., Ltd.

Fecha de decisión2020-01-17

Código de productoDHA

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

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Otros registros que enlistan a Shenzhen New Industries Biomedical Engineering Co., Ltd. como solicitante

K232587MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer K191499MAGLUMI 2000 25-OH Vitamin D K182423MAGLUMI 2000 FT4 K162698MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer

Dispositivos relacionados (Código: DHA)

K233581VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackOrtho Clinical Diagnostics K223690iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)Shenzhen Yhlo Biotech Co., Ltd.K230937Kit de Reagente Alinity i Total ß-hCG, Sistemas de Rastreo GLPAbbott Laboratories K230790Kit de Reagente Alinity i Total ß-hCG, Kit de Reagente Alinity c Glucosa, Disolvente de Muestra Alinity c ICT, Serie Alinity ciAbbott Laboratories K221990Access 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.

Fuente oficial

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