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FDA 510(k)

ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT

K-Number: K981632 · 1998-06-15

ApplicantRoche Diagnostics/Boehringer Mannheim GmbH
Decision Date1998-06-15
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics/Boehringer Mannheim GmbH. It received FDA 510(k) clearance on 1998-06-15 under 510(k) number K981632. 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 ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT?

ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT is a medical device that received FDA 510(k) clearance on 1998-06-15. The listed applicant is Roche Diagnostics/Boehringer Mannheim GmbH. The 510(k) number is K981632.

When did ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT receive FDA 510(k) clearance?

ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT received FDA 510(k) clearance on 1998-06-15, under 510(k) number K981632.

Who is the listed applicant for ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT?

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

What is the FDA product code for ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT?

The FDA product code for ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT is CIG.

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Other records listing Roche Diagnostics/Boehringer Mannheim GmbH as applicant

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K983892COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK PK981931CEDIA RED BLOOD CELL FOLATE REAGENT PACK, CEDIA FOLATE ASSAY AND ELECSYS FOLATE ASSAY

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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