FDA 510(k)

MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer

Numéro K : K232587 · 2024-04-12

DemandeurShenzhen New Industries Biomedical Engineering Co., Ltd.

Date de décision2024-04-12

Code produitMRG

Comité consultatifCH

DécisionSubstantially Equivalent

Résumé du dispositif

MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer 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 2024-04-12 under 510(k) number K232587. The device is classified under product code MRG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer?

MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer is a medical device that received FDA 510(k) clearance on 2024-04-12. The listed applicant is Shenzhen New Industries Biomedical Engineering Co., Ltd.. The 510(k) number is K232587.

When did MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer receive FDA 510(k) clearance?

MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer received FDA 510(k) clearance on 2024-04-12, under 510(k) number K232587.

Who is the listed applicant for MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer?

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 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer?

The FDA product code for MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer is MRG.

Essais cliniques associés

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Autres dossiers indiquant Shenzhen New Industries Biomedical Engineering Co., Ltd. en tant que demandeur

K192547MAGLUMI 2000 HCG/ß-HCG K191499MAGLUMI 2000 25-OH Vitamin D K182423MAGLUMI 2000 FT4 K162698MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer

Dispositifs connexes (Code : MRG)

K221817Analyseur ALFIS de vitamine D, ALFIS-3Immunostics Inc.,K223503Access 25(OH) Vitamin D TotalBeckman Coulter, Inc.K210901Elecsys Vitamin D total IIIRoche Diagnostics K200509ADVIA Centaur Vitamin D Total (VitD)Siemens Healthcare Diagnostics, Inc.K191499MAGLUMI 2000 25-OH Vitamin DShenzhen New Industries Biomedical Engineering Co., Ltd.K180577BioPlex 2200 25-OH Vitamin D KitBio-Rad Laboratories

Source officielle

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