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 a medical device manufactured by Ark Diagnostics, Inc.. It received FDA 510(k) clearance on 2020-02-26 under approval 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. It is manufactured by Ark Diagnostics, Inc.. The 510(k) number is K200197.
When was ARK Fentanyl II Assay approved by the FDA?
ARK Fentanyl II Assay received FDA 510(k) clearance on 2020-02-26, under approval number K200197.
What company makes ARK Fentanyl II Assay?
ARK Fentanyl II Assay is manufactured by Ark Diagnostics, Inc..
What is the FDA product code for ARK Fentanyl II Assay?
The FDA product code for ARK Fentanyl II Assay is DJG.
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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.