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FDA 510(k)

COMPUR* EASYTOUCH TOTAL BILIRUBIN

K-Number: K832748 · 1983-10-14

ApplicantWorthington Diagnostic Systems
Decision Date1983-10-14
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COMPUR* EASYTOUCH TOTAL BILIRUBIN is the device name listed in this FDA 510(k) record. The listed applicant is Worthington Diagnostic Systems. It received FDA 510(k) clearance on 1983-10-14 under 510(k) number K832748. 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 COMPUR* EASYTOUCH TOTAL BILIRUBIN?

COMPUR* EASYTOUCH TOTAL BILIRUBIN is a medical device that received FDA 510(k) clearance on 1983-10-14. The listed applicant is Worthington Diagnostic Systems. The 510(k) number is K832748.

When did COMPUR* EASYTOUCH TOTAL BILIRUBIN receive FDA 510(k) clearance?

COMPUR* EASYTOUCH TOTAL BILIRUBIN received FDA 510(k) clearance on 1983-10-14, under 510(k) number K832748.

Who is the listed applicant for COMPUR* EASYTOUCH TOTAL BILIRUBIN?

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

What is the FDA product code for COMPUR* EASYTOUCH TOTAL BILIRUBIN?

The FDA product code for COMPUR* EASYTOUCH TOTAL BILIRUBIN is CIG.

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Other records listing Worthington Diagnostic Systems 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.

K833708COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTEK832749EASYTOUCH BUN REAGENT SETK832785COMPUR* EASY TOUCH URIC ACID REAGENTK832427EASYTOUCH TROMBOPLASTIN REAGENTK832750EASYTOUCH HEMOGLOBIN REAGENTK832426EASYTOUCH TRIGLYCERIDES REAGENT SET

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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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