MAGLUMI 2000 HCG/ß-HCG

System, Test, Human Chorionic Gonadotropin

Shenzhen New Industries Biomedical Engineering Co., Ltd

The following data is part of a premarket notification filed by Shenzhen New Industries Biomedical Engineering Co., Ltd with the FDA for Maglumi 2000 Hcg/ß-hcg.

Pre-market Notification Details

Device IDK192547
510k NumberK192547
Device Name:MAGLUMI 2000 HCG/ß-HCG
ClassificationSystem, Test, Human Chorionic Gonadotropin
Applicant Shenzhen New Industries Biomedical Engineering Co., Ltd No.16, Jinhui Road, Pingshan New District Shenzhen,  CN 518122
ContactJie Rao
CorrespondentJoe Shia
LSI International Inc 504E Diamond Ave., Suite F Gaithersburg,  MD  20877
Product CodeDHA  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyClinical Chemistry
510k Review PanelClinical Chemistry
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-17
Decision Date2020-01-17

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