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FDA 510(k)

COBAS C BILIRUBIN TOTAL GEN.3

K-Number: K131544 · 2013-07-17

ApplicantRoche Diagnostics
Decision Date2013-07-17
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COBAS C BILIRUBIN TOTAL GEN.3 is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2013-07-17 under 510(k) number K131544. The device is classified under product code CIG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBAS C BILIRUBIN TOTAL GEN.3?

COBAS C BILIRUBIN TOTAL GEN.3 is a medical device that received FDA 510(k) clearance on 2013-07-17. The listed applicant is Roche Diagnostics. The 510(k) number is K131544.

When did COBAS C BILIRUBIN TOTAL GEN.3 receive FDA 510(k) clearance?

COBAS C BILIRUBIN TOTAL GEN.3 received FDA 510(k) clearance on 2013-07-17, under 510(k) number K131544.

Who is the listed applicant for COBAS C BILIRUBIN TOTAL GEN.3?

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

What is the FDA product code for COBAS C BILIRUBIN TOTAL GEN.3?

The FDA product code for COBAS C BILIRUBIN TOTAL GEN.3 is CIG.

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Related Devices (Code: CIG)

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.

K251998Atellica CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc.K223078Atellica® CH Diazo Direct Bilirubin (D_DBil)Siemens Healthcare Diagnostics, Inc.K222104Atellica® CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc.K223324Total Bilirubin2Abbott Ireland Diagnostics DivisionK190807VITROS XT Chemistry Products TBIL-ALKP SlidesOrtho-Clinical Diagnostics, Inc.K171401ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1Elitechgroup

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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