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FDA 510(k)

SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana

K-Number: K153646 · 2016-03-18

ApplicantSafecare Biotech (Hangzhou) Co., Ltd.
Decision Date2016-03-18
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana is a medical device manufactured by Safecare Biotech (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2016-03-18 under approval number K153646. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana?

SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana is a medical device that received FDA 510(k) clearance on 2016-03-18. It is manufactured by Safecare Biotech (Hangzhou) Co., Ltd.. The 510(k) number is K153646.

When was SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana approved by the FDA?

SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana received FDA 510(k) clearance on 2016-03-18, under approval number K153646.

What company makes SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana?

SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana is manufactured by Safecare Biotech (Hangzhou) Co., Ltd..

What is the FDA product code for SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana?

The FDA product code for SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana is DIO.

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

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 K191924SAFECARE® THC Urine Strip Test 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: DIO)

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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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