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FDA 510(k)

TOTAL BILIRUBIN REAGENT

K-Number: K840486 · 1984-04-25

ApplicantSomas Medical Industries, Inc.
Decision Date1984-04-25
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TOTAL BILIRUBIN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Somas Medical Industries, Inc.. It received FDA 510(k) clearance on 1984-04-25 under 510(k) number K840486. 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?

TOTAL BILIRUBIN REAGENT is a medical device that received FDA 510(k) clearance on 1984-04-25. The listed applicant is Somas Medical Industries, Inc.. The 510(k) number is K840486.

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

TOTAL BILIRUBIN REAGENT received FDA 510(k) clearance on 1984-04-25, under 510(k) number K840486.

Who is the listed applicant for TOTAL BILIRUBIN REAGENT?

The FDA 510(k) record lists Somas Medical Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOTAL BILIRUBIN REAGENT?

The FDA product code for TOTAL BILIRUBIN REAGENT is CIG.

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Other records listing Somas Medical Industries, 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.

K862179SOMAS LIQUID URINE CONTROLK842134SOMAS COOMASIE BLUE TOTAL PROTEIN ASSAYK840974SOMAS HUMAN SPINAL FLUID CONTROLK840485TOTAL IRON UIBC/TIBC ASSAYK833787SOMAS CHLORIDE ASSAY KIT

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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