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510(k) K192547

MAGLUMI 2000 HCG/ß-HCG by Shenzhen New Industries Biomedical Engineering Co., Ltd. — Product Code DHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2020
Date Received
September 17, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Human Chorionic Gonadotropin
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

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