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Safecare Biotech (Hangzhou) Co., Ltd.

FDA 510(k) & PMA Approved Devices — 9 products

Total Devices9
Categories7
Latest FDA decision2025-01-10
TypeNumberDevice NameCodeDateActions
510(k) K242767 Safecare Urinary Tract Infection TestJMT2025-01-10 View
510(k) K240654 SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test CassetteNGL2024-04-10 View
510(k) K202453 SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-CardNFT2021-03-24 View
510(k) K200133 hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test MidstreamLCX2020-08-13 View
510(k) K201120 SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip CardNFT2020-05-27 View
510(k) K191924 SAFECARE® THC Urine Strip TestNFW2019-08-16 View
510(k) K182654 SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip CardNGG2018-11-19 View
510(k) K181968 SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-CardNFT2018-08-20 View
510(k) K153646 SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test MarijuanaDIO2016-03-18 View