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FDA 510(k)

BILIRUBIN(TOTAL) DETERMINATION CTMS

K-Number: K820675 · 1982-04-01

ApplicantThe Dow Chemical Co.
Decision Date1982-04-01
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BILIRUBIN(TOTAL) DETERMINATION CTMS is the device name listed in this FDA 510(k) record. The listed applicant is The Dow Chemical Co.. It received FDA 510(k) clearance on 1982-04-01 under 510(k) number K820675. 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 BILIRUBIN(TOTAL) DETERMINATION CTMS?

BILIRUBIN(TOTAL) DETERMINATION CTMS is a medical device that received FDA 510(k) clearance on 1982-04-01. The listed applicant is The Dow Chemical Co.. The 510(k) number is K820675.

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

BILIRUBIN(TOTAL) DETERMINATION CTMS received FDA 510(k) clearance on 1982-04-01, under 510(k) number K820675.

Who is the listed applicant for BILIRUBIN(TOTAL) DETERMINATION CTMS?

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

What is the FDA product code for BILIRUBIN(TOTAL) DETERMINATION CTMS?

The FDA product code for BILIRUBIN(TOTAL) DETERMINATION CTMS is CIG.

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Other records listing The Dow Chemical 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.

K823474ENZYMATIC GLUCOSE DETERMINATIONK822154UREA NITROGEN (ENZYMATIC) DETERMINATIONK821536DOWFLOW ALT-UV DETERMINATIONK821315DOWFLOW ENZYMATIC TRIGLYCERIDES DETERMK820714DOW BILIRUBIN(DIRECT) DETERMINATIONK812777DIRECT IRON 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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