MAGLUMI 2000 25-OH Vitamin D— 510(k) K191499

Substantially Equivalent

Shenzhen New Industries Biomedical Engineering Co., Ltd.

FDA 510(k) clearance K191499 for MAGLUMI 2000 25-OH Vitamin D, Substantially Equivalent on 2019-08-01. Applicant: Shenzhen New Industries Biomedical Engineering Co., Ltd..

Clearance details

Applicant: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Product code: Code MRG
Advisory panel: Clinical Chemistry
Date received: 2019-06-06
Decision date: 2019-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

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