ARK Hydrocodone Assay
K-Number: K231752 · 2023-11-09
ApplicantArk Diagnostics, Inc.
Decision Date2023-11-09
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent
Device Summary
ARK Hydrocodone Assay is a medical device manufactured by Ark Diagnostics, Inc.. It received FDA 510(k) clearance on 2023-11-09 under approval number K231752. 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 Hydrocodone Assay?
ARK Hydrocodone Assay is a medical device that received FDA 510(k) clearance on 2023-11-09. It is manufactured by Ark Diagnostics, Inc.. The 510(k) number is K231752.
When was ARK Hydrocodone Assay approved by the FDA?
ARK Hydrocodone Assay received FDA 510(k) clearance on 2023-11-09, under approval number K231752.
What company makes ARK Hydrocodone Assay?
ARK Hydrocodone Assay is manufactured by Ark Diagnostics, Inc..
What is the FDA product code for ARK Hydrocodone Assay?
The FDA product code for ARK Hydrocodone 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.