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FDA 510(k)

BILIRUBIN-SL (TOTAL) ASSAY

K-Number: K974874 · 1998-02-12

ApplicantDiagnostic Chemicals, Ltd. (Usa)
Decision Date1998-02-12
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BILIRUBIN-SL (TOTAL) ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). It received FDA 510(k) clearance on 1998-02-12 under 510(k) number K974874. 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-SL (TOTAL) ASSAY?

BILIRUBIN-SL (TOTAL) ASSAY is a medical device that received FDA 510(k) clearance on 1998-02-12. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). The 510(k) number is K974874.

When did BILIRUBIN-SL (TOTAL) ASSAY receive FDA 510(k) clearance?

BILIRUBIN-SL (TOTAL) ASSAY received FDA 510(k) clearance on 1998-02-12, under 510(k) number K974874.

Who is the listed applicant for BILIRUBIN-SL (TOTAL) ASSAY?

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

What is the FDA product code for BILIRUBIN-SL (TOTAL) ASSAY?

The FDA product code for BILIRUBIN-SL (TOTAL) ASSAY is CIG.

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Other records listing Diagnostic Chemicals, Ltd. (Usa) 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.

K022538IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25K932556AMMONIA ASSAY CAT. NO. 200-02K932766HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)K932555DC-LINEATE CAT. NO. SE-091K925877DC-UIBC-CALK912825MAGNESIUM ASSAY KIT, CAT.# 100-12

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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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