Name: Predicase
Price: 199 USD

K-number	K192123
Device name	HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream
Applicant	Qingdao Hightop Biotech Co., Ltd.
Product code	LCX
Device class	Class II
Decision date	Sep 5, 2019
Decision	Substantially Equivalent
Regulation	862.1155

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Source

View the full FDA submission: accessdata.fda.gov

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HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream

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