Evidence MultiSTAT DOA Urine MultiPlex
K-Number: K221550 · 2023-10-05
ApplicantRandox Laboratories Limited
Decision Date2023-10-05
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent
Device Summary
Evidence MultiSTAT DOA Urine MultiPlex is a medical device manufactured by Randox Laboratories Limited. It received FDA 510(k) clearance on 2023-10-05 under approval number K221550. 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 Evidence MultiSTAT DOA Urine MultiPlex?
Evidence MultiSTAT DOA Urine MultiPlex is a medical device that received FDA 510(k) clearance on 2023-10-05. It is manufactured by Randox Laboratories Limited. The 510(k) number is K221550.
When was Evidence MultiSTAT DOA Urine MultiPlex approved by the FDA?
Evidence MultiSTAT DOA Urine MultiPlex received FDA 510(k) clearance on 2023-10-05, under approval number K221550.
What company makes Evidence MultiSTAT DOA Urine MultiPlex?
Evidence MultiSTAT DOA Urine MultiPlex is manufactured by Randox Laboratories Limited.
What is the FDA product code for Evidence MultiSTAT DOA Urine MultiPlex?
The FDA product code for Evidence MultiSTAT DOA Urine MultiPlex 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.