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510(k) K112315

HOME PREGNANCY TEST by Newscen Coast Bio-Pharmaceutical Co., Ltd. — Product Code JHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2012
Date Received
August 11, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Visual, Pregnancy Hcg, Prescription Use
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

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