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FDA 510(k)

BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip

K-Number: K192301 · 2019-09-20

ApplicantShenzhen Bioeasy Biotechnology Co., Ltd.
Decision Date2019-09-20
Product CodeNFW
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip is a medical device manufactured by Shenzhen Bioeasy Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2019-09-20 under approval number K192301. 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 BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip?

BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip is a medical device that received FDA 510(k) clearance on 2019-09-20. It is manufactured by Shenzhen Bioeasy Biotechnology Co., Ltd.. The 510(k) number is K192301.

When was BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip approved by the FDA?

BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip received FDA 510(k) clearance on 2019-09-20, under approval number K192301.

What company makes BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip?

BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip is manufactured by Shenzhen Bioeasy Biotechnology Co., Ltd..

What is the FDA product code for BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip?

The FDA product code for BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip is NFW.

Other Devices by Shenzhen Bioeasy Biotechnology Co., Ltd.

K182530BIOEASY Multi-Drug Test Cup K192515BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20 K193480BIOEASY Multi-Drug Test Cup K230238BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx

Related Devices (Code: NFW)

K191924SAFECARE® THC Urine Strip TestSafecare Biotech (Hangzhou) 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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