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FDA 510(k)

BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx

K-Number: K230238 · 2023-03-31

Decision Date2023-03-31
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx is a medical device manufactured by Shenzhen Bioeasy Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2023-03-31 under approval number K230238. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx?

BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx is a medical device that received FDA 510(k) clearance on 2023-03-31. It is manufactured by Shenzhen Bioeasy Biotechnology Co., Ltd.. The 510(k) number is K230238.

When was BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx approved by the FDA?

BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx received FDA 510(k) clearance on 2023-03-31, under approval number K230238.

What company makes BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx?

BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx is manufactured by Shenzhen Bioeasy Biotechnology Co., Ltd..

What is the FDA product code for BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx?

The FDA product code for BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx is DJG.

Other Devices by Shenzhen Bioeasy Biotechnology Co., Ltd.

Related Devices (Code: DJG)

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.