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FDA 510(k)

A-GENT LIQUID TOTAL BILIRUBIN

K-Number: K860424 · 1986-04-03

ApplicantAbbott Laboratories
Decision Date1986-04-03
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

A-GENT LIQUID TOTAL BILIRUBIN is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1986-04-03 under 510(k) number K860424. 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 A-GENT LIQUID TOTAL BILIRUBIN?

A-GENT LIQUID TOTAL BILIRUBIN is a medical device that received FDA 510(k) clearance on 1986-04-03. The listed applicant is Abbott Laboratories. The 510(k) number is K860424.

When did A-GENT LIQUID TOTAL BILIRUBIN receive FDA 510(k) clearance?

A-GENT LIQUID TOTAL BILIRUBIN received FDA 510(k) clearance on 1986-04-03, under 510(k) number K860424.

Who is the listed applicant for A-GENT LIQUID TOTAL BILIRUBIN?

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

What is the FDA product code for A-GENT LIQUID TOTAL BILIRUBIN?

The FDA product code for A-GENT LIQUID TOTAL BILIRUBIN 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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