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FDA 510(k)

BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20

K-Number: K192515 · 2019-10-11

ApplicantShenzhen Bioeasy Biotechnology Co., Ltd.
Decision Date2019-10-11
Product CodeLDJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Bioeasy Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2019-10-11 under 510(k) number K192515. The device is classified under product code LDJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20?

BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20 is a medical device that received FDA 510(k) clearance on 2019-10-11. The listed applicant is Shenzhen Bioeasy Biotechnology Co., Ltd.. The 510(k) number is K192515.

When did BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20 receive FDA 510(k) clearance?

BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20 received FDA 510(k) clearance on 2019-10-11, under 510(k) number K192515.

Who is the listed applicant for BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20?

The FDA 510(k) record lists Shenzhen Bioeasy Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20?

The FDA product code for BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20 is LDJ.

Other records listing Shenzhen Bioeasy Biotechnology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230238BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup RxK193480BIOEASY Multi-Drug Test CupK192301BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test StripK182530BIOEASY Multi-Drug Test Cup

Related Devices (Code: LDJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232732Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50Co-Innovation Biotech Co., Ltd.K232604LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette)Hangzhou Laihe Biotech Co., Ltd.K223162Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COTHealgen Scientific,, LLCK153741CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana TestHangzhou Clongene Biotech Co., Ltd.

Official Source

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

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