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FDA 510(k)

ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card

K-Number: K201494 · 2020-09-17

Decision Date2020-09-17
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card is a medical device manufactured by Advin Biotech, Inc.. It received FDA 510(k) clearance on 2020-09-17 under approval number K201494. 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 ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card?

ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card is a medical device that received FDA 510(k) clearance on 2020-09-17. It is manufactured by Advin Biotech, Inc.. The 510(k) number is K201494.

When was ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card approved by the FDA?

ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card received FDA 510(k) clearance on 2020-09-17, under approval number K201494.

What company makes ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card?

ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card is manufactured by Advin Biotech, Inc..

What is the FDA product code for ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card?

The FDA product code for ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card is DJG.

Other Devices by Advin Biotech, Inc.

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.