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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Vitamin D
510(k) Number K232587
Device Name MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer
Applicant
Shenzhen New Industries Biomedical Engineering Co., Ltd.
#16, Jinhui Rd., Pingshan New District
Shenzhen,  CN 518122
Applicant Contact Xiaoli Wang
Correspondent
LSI International, Inc.
504 E Diamond Ave.
Suite H
Gaithersburg,  MD  20877
Correspondent Contact Joe Shia
Regulation Number862.1825
Classification Product Code
MRG  
Subsequent Product Code
JJE  
Date Received08/25/2023
Decision Date 04/12/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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