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510(k) K191924

Device
SAFECARE® THC Urine Strip Test
Applicant
Safecare Biotech (Hangzhou) Co., Ltd.
510(k) number
K191924
Product code
NFW  
Decision
Substantially Equivalent (SESE)
Decision date
2019-08-16
Date received
2019-07-18
Regulation
862.3870
Classification name
Test, Cannabinoid, Over The Counter
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Alex Qiu
Address
Bldg. 2/203 #18 Haishu Rd., Cangqian Sub-District Yuhang District Hangzhou CN 311121 311121

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NFW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252523Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug TestHealgen Scientific,, LLC2026-02-12
K231978BioSieve™ Marijuana Test Panel 50; BioSieve™ Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Strip 20; BioSieve™ Dx Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Panel 20; BioSieve™ Dx Marijuana Test Panel 50Vivachek Biotech (Hangzhou) Co., Ltd.2023-08-31
K192301BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test StripShenzhen Bioeasy Biotechnology Co., Ltd.2019-09-20

Legacy Summary#

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FDA Review#

Decision Summary