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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Randox Laboratories Limited. It received FDA 510(k) clearance on 2016-01-28 under 510(k) 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. The listed applicant is Randox Laboratories Limited. The 510(k) number is K152344.

When did Total Bilirubin receive FDA 510(k) clearance?

Total Bilirubin received FDA 510(k) clearance on 2016-01-28, under 510(k) number K152344.

Who is the listed applicant for Total Bilirubin?

The FDA 510(k) record lists Randox Laboratories Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Total Bilirubin?

The FDA product code for Total Bilirubin is JFM.

Other records listing Randox Laboratories Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250741Evidence MultiSTAT DOA Urine MultiPlexK221550Evidence MultiSTAT DOA Urine MultiPlexK220451Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTATK230890ISE ElectrodesK182042Randox Calcium (Ca)K162200Randox RX Daytona Plus Magnesium (MG)

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Related Devices (Code: JFM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K170065ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)Siemens Healthcare Diagnostics, Inc.K152343Direct BilirubinRandox Laboratories Limited

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.

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