ARK EDDP Assay
K-Number: K182779 · 2018-11-21
ApplicantArk Diagnostics, Inc.
Decision Date2018-11-21
Product CodeDJR
Advisory CommitteeTX
DecisionSubstantially Equivalent
Device Summary
ARK EDDP Assay is a medical device manufactured by Ark Diagnostics, Inc.. It received FDA 510(k) clearance on 2018-11-21 under approval number K182779. The device is classified under product code DJR. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ARK EDDP Assay?
ARK EDDP Assay is a medical device that received FDA 510(k) clearance on 2018-11-21. It is manufactured by Ark Diagnostics, Inc.. The 510(k) number is K182779.
When was ARK EDDP Assay approved by the FDA?
ARK EDDP Assay received FDA 510(k) clearance on 2018-11-21, under approval number K182779.
What company makes ARK EDDP Assay?
ARK EDDP Assay is manufactured by Ark Diagnostics, Inc..
What is the FDA product code for ARK EDDP Assay?
The FDA product code for ARK EDDP Assay is DJR.
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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.