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FDA 510(k)

BILIRUBIN, DINGLE VALVE DPD

K-Number: K781921 · 1979-01-03

ApplicantBoehringer Mannheim Corp.
Decision Date1979-01-03
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BILIRUBIN, DINGLE VALVE DPD is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1979-01-03 under 510(k) number K781921. 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, DINGLE VALVE DPD?

BILIRUBIN, DINGLE VALVE DPD is a medical device that received FDA 510(k) clearance on 1979-01-03. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K781921.

When did BILIRUBIN, DINGLE VALVE DPD receive FDA 510(k) clearance?

BILIRUBIN, DINGLE VALVE DPD received FDA 510(k) clearance on 1979-01-03, under 510(k) number K781921.

Who is the listed applicant for BILIRUBIN, DINGLE VALVE DPD?

The FDA 510(k) record lists Boehringer Mannheim Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BILIRUBIN, DINGLE VALVE DPD?

The FDA product code for BILIRUBIN, DINGLE VALVE DPD is CIG.

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Other records listing Boehringer Mannheim Corp. as applicant

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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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