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FDA 510(k)

COBAS TOTAL BILIRUBIN REAGENT & DILUENT

K-Number: K801117 · 1980-06-09

ApplicantRoche Analytical Instruments, Inc.
Decision Date1980-06-09
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COBAS TOTAL BILIRUBIN REAGENT & DILUENT is the device name listed in this FDA 510(k) record. The listed applicant is Roche Analytical Instruments, Inc.. It received FDA 510(k) clearance on 1980-06-09 under 510(k) number K801117. 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 TOTAL BILIRUBIN REAGENT & DILUENT?

COBAS TOTAL BILIRUBIN REAGENT & DILUENT is a medical device that received FDA 510(k) clearance on 1980-06-09. The listed applicant is Roche Analytical Instruments, Inc.. The 510(k) number is K801117.

When did COBAS TOTAL BILIRUBIN REAGENT & DILUENT receive FDA 510(k) clearance?

COBAS TOTAL BILIRUBIN REAGENT & DILUENT received FDA 510(k) clearance on 1980-06-09, under 510(k) number K801117.

Who is the listed applicant for COBAS TOTAL BILIRUBIN REAGENT & DILUENT?

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

What is the FDA product code for COBAS TOTAL BILIRUBIN REAGENT & DILUENT?

The FDA product code for COBAS TOTAL BILIRUBIN REAGENT & DILUENT is CIG.

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Other records listing Roche Analytical Instruments, Inc. 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.

K801299COBAS CK-NAC REAGENTK801295COBAS REAGENT FOR A-AMYLASEK801298COBAS REAGENT FOR TRIGLYCERIDES & COBASK801296COBAS REAGENT FOR CHOLESTEROLK801297COBAS REAGENT FOR GLUCOSE RAPIDK801243COBAS REAGENTS FOR URIC ACID

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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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