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FDA 510(k)

ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card

K-Number: K201494 · 2020-09-17

ApplicantAdvin Biotech, Inc.
Decision Date2020-09-17
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card is the device name listed in this FDA 510(k) record. The listed applicant is Advin Biotech, Inc.. It received FDA 510(k) clearance on 2020-09-17 under 510(k) 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. The listed applicant is Advin Biotech, Inc.. The 510(k) number is K201494.

When did ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card receive FDA 510(k) clearance?

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

Who is the listed applicant for ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card?

The FDA 510(k) record lists Advin Biotech, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Advin Biotech, Inc. 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.

K252867VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test CupK182123ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card

Related Devices (Code: DJG)

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.

K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc.K250741Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories LimitedK253082LZI Buprenorphine II Enzyme ImmunoassayLin-Zhi International, Inc.K252520SEFRIA™ Hydrocodone Oral FluidImmunalysis CorporationK251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)Healgen Scientific,, LLCK251634LZI Fentanyl III Enzyme ImmunoassayLin-Zhi International, Inc.

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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