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FDA 510(k)

KING DIAGNOSTICS TOTAL BILIRUBIN TEST

K-Number: K811881 · 1981-07-23

ApplicantKing Diagnostics, Inc.
Decision Date1981-07-23
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

KING DIAGNOSTICS TOTAL BILIRUBIN TEST is the device name listed in this FDA 510(k) record. The listed applicant is King Diagnostics, Inc.. It received FDA 510(k) clearance on 1981-07-23 under 510(k) number K811881. 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 KING DIAGNOSTICS TOTAL BILIRUBIN TEST?

KING DIAGNOSTICS TOTAL BILIRUBIN TEST is a medical device that received FDA 510(k) clearance on 1981-07-23. The listed applicant is King Diagnostics, Inc.. The 510(k) number is K811881.

When did KING DIAGNOSTICS TOTAL BILIRUBIN TEST receive FDA 510(k) clearance?

KING DIAGNOSTICS TOTAL BILIRUBIN TEST received FDA 510(k) clearance on 1981-07-23, under 510(k) number K811881.

Who is the listed applicant for KING DIAGNOSTICS TOTAL BILIRUBIN TEST?

The FDA 510(k) record lists King Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KING DIAGNOSTICS TOTAL BILIRUBIN TEST?

The FDA product code for KING DIAGNOSTICS TOTAL BILIRUBIN TEST is CIG.

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Other records listing King Diagnostics, Inc. 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.

K933329KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENTK931834KING SODIUM/POTASSIUM STANDARD MODIFIEDK931773HDL PRECIPITATING REAGENT (DEXTRAN SULFATE)K931326KING DIAGNOSTICS CK REAGENTK923129KING DIAGNOSTICS GLUCOSE (HK) REAGENTK922969KING DIAGNOSTICS UREA NITROGEN REAGENT

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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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