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510(k) K162698

MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer by Shenzhen New Industries Biomedical Engineering Co., Ltd. — Product Code JLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2017
Date Received
September 27, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Thyroid-Stimulating Hormone
Device Class
Class II
Regulation Number
862.1690
Review Panel
CH
Submission Type

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