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510(k) K192123

HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream by Qingdao Hightop Biotech Co., Ltd. — Product Code LCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 2019
Date Received
August 6, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

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