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MAGLUMI 2000 25-OH Vitamin D

FDA 510(k)

Class II (US FDA 510(k))

510(k) K191499

by Shenzhen New Industries Biomedical Engineering Co., Ltd.

Identifiers

510(k) Number: K191499 FDA 510(k)
FDA Product Code: MRG FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 862.1825 FDA 510(k)
Regulation Number: 862.1825 FDA 510(k)
Advisory Committee: Clinical Chemistry FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

MAGLUMI 2000 25-OH Vitamin D by Shenzhen New Industries Biomedical Engineering Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.

Sources (1)

FDA 510(k) K191499 24 fields · synced Jun 18, 2026