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FDA 510(k)

DIRECT BILIRUBIN (DND) ASSAY, CATALOGUE NUMBER 209-05

K-Number: K955880 · 1996-08-27

ApplicantDiagnostic Chemicals , Ltd.
Decision Date1996-08-27
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIRECT BILIRUBIN (DND) ASSAY, CATALOGUE NUMBER 209-05 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals , Ltd.. It received FDA 510(k) clearance on 1996-08-27 under 510(k) number K955880. 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 DIRECT BILIRUBIN (DND) ASSAY, CATALOGUE NUMBER 209-05?

DIRECT BILIRUBIN (DND) ASSAY, CATALOGUE NUMBER 209-05 is a medical device that received FDA 510(k) clearance on 1996-08-27. The listed applicant is Diagnostic Chemicals , Ltd.. The 510(k) number is K955880.

When did DIRECT BILIRUBIN (DND) ASSAY, CATALOGUE NUMBER 209-05 receive FDA 510(k) clearance?

DIRECT BILIRUBIN (DND) ASSAY, CATALOGUE NUMBER 209-05 received FDA 510(k) clearance on 1996-08-27, under 510(k) number K955880.

Who is the listed applicant for DIRECT BILIRUBIN (DND) ASSAY, CATALOGUE NUMBER 209-05?

The FDA 510(k) record lists Diagnostic Chemicals , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIRECT BILIRUBIN (DND) ASSAY, CATALOGUE NUMBER 209-05?

The FDA product code for DIRECT BILIRUBIN (DND) ASSAY, CATALOGUE NUMBER 209-05 is CIG.

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Other records listing Diagnostic Chemicals , Ltd. 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.

K070383ENZYMATIC CREATININE ASSAY (265 SERIES)K063208MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7K060139CRP-ADVANCE ASSAY, MODELS 250-20, 250-25K060140CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250K051757CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91K051191DCL MICROALBUMIN ASSAY, MODEL 252-20

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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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