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510(k) K200133

hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream by Safecare Biotech (Hangzhou) Co., Ltd. — Product Code LCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2020
Date Received
January 21, 2020
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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  • K153646 — SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Tes (March 18, 2016)

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