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FDA 510(k)

SAFECARE® THC Urine Strip Test

K-Number: K191924 · 2019-08-16

ApplicantSafecare Biotech (Hangzhou) Co., Ltd.
Decision Date2019-08-16
Product CodeNFW
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SAFECARE® THC Urine Strip Test is a medical device manufactured by Safecare Biotech (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2019-08-16 under approval number K191924. The device is classified under product code NFW. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAFECARE® THC Urine Strip Test?

SAFECARE® THC Urine Strip Test is a medical device that received FDA 510(k) clearance on 2019-08-16. It is manufactured by Safecare Biotech (Hangzhou) Co., Ltd.. The 510(k) number is K191924.

When was SAFECARE® THC Urine Strip Test approved by the FDA?

SAFECARE® THC Urine Strip Test received FDA 510(k) clearance on 2019-08-16, under approval number K191924.

What company makes SAFECARE® THC Urine Strip Test?

SAFECARE® THC Urine Strip Test is manufactured by Safecare Biotech (Hangzhou) Co., Ltd..

What is the FDA product code for SAFECARE® THC Urine Strip Test?

The FDA product code for SAFECARE® THC Urine Strip Test is NFW.

Other Devices by Safecare Biotech (Hangzhou) Co., Ltd.

K153646SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana K182654SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card K181968SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card K200133hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream K201120SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card K202453SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card

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Related Devices (Code: NFW)

K192301BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test StripShenzhen Bioeasy Biotechnology Co., Ltd. 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. K252523Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug TestHealgen Scientific,, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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