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FDA 510(k)

IL TEST BILIRUBIN TOTAL/DIRECT

K-Number: K920653 · 1992-07-23

ApplicantInstrumentation Laboratory CO
Decision Date1992-07-23
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IL TEST BILIRUBIN TOTAL/DIRECT is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 1992-07-23 under 510(k) number K920653. 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 IL TEST BILIRUBIN TOTAL/DIRECT?

IL TEST BILIRUBIN TOTAL/DIRECT is a medical device that received FDA 510(k) clearance on 1992-07-23. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K920653.

When did IL TEST BILIRUBIN TOTAL/DIRECT receive FDA 510(k) clearance?

IL TEST BILIRUBIN TOTAL/DIRECT received FDA 510(k) clearance on 1992-07-23, under 510(k) number K920653.

Who is the listed applicant for IL TEST BILIRUBIN TOTAL/DIRECT?

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

What is the FDA product code for IL TEST BILIRUBIN TOTAL/DIRECT?

The FDA product code for IL TEST BILIRUBIN TOTAL/DIRECT is CIG.

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Other records listing Instrumentation Laboratory CO 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.

K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMK223187HemosIL Liquid Anti-XaK223090GEM Premier ChemSTATK223402HemosIL von Willebrand Factor AntigenK213464HemosIL Liquid Anti-XaK213426HemosIL ReadiPlasTin

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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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