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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Randox Laboratories Limited. It received FDA 510(k) clearance on 2016-02-16 under 510(k) 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. The listed applicant is Randox Laboratories Limited. The 510(k) number is K152343.

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

Direct Bilirubin received FDA 510(k) clearance on 2016-02-16, under 510(k) number K152343.

Who is the listed applicant for Direct 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 Direct Bilirubin?

The FDA product code for Direct Bilirubin is JFM.

Other records listing Randox Laboratories Limited as applicant

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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.K152344Total 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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