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FDA 510(k)

ARK Fentanyl II Assay

K-Number: K200197 · 2020-02-26

ApplicantArk Diagnostics, Inc.
Decision Date2020-02-26
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ARK Fentanyl II Assay is the device name listed in this FDA 510(k) record. The listed applicant is Ark Diagnostics, Inc.. It received FDA 510(k) clearance on 2020-02-26 under 510(k) number K200197. 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 ARK Fentanyl II Assay?

ARK Fentanyl II Assay is a medical device that received FDA 510(k) clearance on 2020-02-26. The listed applicant is Ark Diagnostics, Inc.. The 510(k) number is K200197.

When did ARK Fentanyl II Assay receive FDA 510(k) clearance?

ARK Fentanyl II Assay received FDA 510(k) clearance on 2020-02-26, under 510(k) number K200197.

Who is the listed applicant for ARK Fentanyl II Assay?

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

What is the FDA product code for ARK Fentanyl II Assay?

The FDA product code for ARK Fentanyl II Assay is DJG.

Other records listing Ark Diagnostics, 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.

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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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