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FDA 510(k)

TOTAL BILIRUBIN REAGENT SET

K-Number: K821197 · 1982-07-13

ApplicantOmega Medical Electronics
Decision Date1982-07-13
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TOTAL BILIRUBIN REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Omega Medical Electronics. It received FDA 510(k) clearance on 1982-07-13 under 510(k) number K821197. 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 TOTAL BILIRUBIN REAGENT SET?

TOTAL BILIRUBIN REAGENT SET is a medical device that received FDA 510(k) clearance on 1982-07-13. The listed applicant is Omega Medical Electronics. The 510(k) number is K821197.

When did TOTAL BILIRUBIN REAGENT SET receive FDA 510(k) clearance?

TOTAL BILIRUBIN REAGENT SET received FDA 510(k) clearance on 1982-07-13, under 510(k) number K821197.

Who is the listed applicant for TOTAL BILIRUBIN REAGENT SET?

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

What is the FDA product code for TOTAL BILIRUBIN REAGENT SET?

The FDA product code for TOTAL BILIRUBIN REAGENT SET is CIG.

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Other records listing Omega Medical Electronics 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.

K823691PHOSPHORUS REAGENT SETK821212UREA NITROGEN REAGENT SETK821206SGPT-UV REAGENT SETK821204GLUCOSE(ENZYMATIC) REAGENT SETK821208SGOT-UV REAGENT SETK821205TRIGLYCERIDE 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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