Name: Predicase
Price: 199 USD

K-number	K203246
Device name	Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream)
Applicant	Atlas Link Technology Co., Ltd.
Product code	LCX
Device class	Class II
Decision date	Aug 4, 2021
Decision	Substantially Equivalent
Regulation	862.1155

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream)

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