Direct Bilirubin
K-Number: K152343 · 2016-02-16
ApplicantRandox Laboratories Limited
Decision Date2016-02-16
Product CodeJFM
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Direct Bilirubin is a medical device manufactured by Randox Laboratories Limited. It received FDA 510(k) clearance on 2016-02-16 under approval number K152343. 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 Direct Bilirubin?
Direct Bilirubin is a medical device that received FDA 510(k) clearance on 2016-02-16. It is manufactured by Randox Laboratories Limited. The 510(k) number is K152343.
When was Direct Bilirubin approved by the FDA?
Direct Bilirubin received FDA 510(k) clearance on 2016-02-16, under approval number K152343.
What company makes Direct Bilirubin?
Direct Bilirubin is manufactured by Randox Laboratories Limited.
What is the FDA product code for Direct Bilirubin?
The FDA product code for Direct Bilirubin is JFM.
Other Devices by Randox Laboratories Limited
Related Devices (Code: JFM)
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.