Total Bilirubin
K-Number: K152344 · 2016-01-28
ApplicantRandox Laboratories Limited
Decision Date2016-01-28
Product CodeJFM
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Total Bilirubin is a medical device manufactured by Randox Laboratories Limited. It received FDA 510(k) clearance on 2016-01-28 under approval number K152344. The device is classified under product code JFM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Total Bilirubin?
Total Bilirubin is a medical device that received FDA 510(k) clearance on 2016-01-28. It is manufactured by Randox Laboratories Limited. The 510(k) number is K152344.
When was Total Bilirubin approved by the FDA?
Total Bilirubin received FDA 510(k) clearance on 2016-01-28, under approval number K152344.
What company makes Total Bilirubin?
Total Bilirubin is manufactured by Randox Laboratories Limited.
What is the FDA product code for Total Bilirubin?
The FDA product code for Total Bilirubin is JFM.
Related Clinical Trials
Other Devices by Randox Laboratories Limited
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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.