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FDA 510(k)

BILIRUBIN DETERMINTAITON IN SERUM

K-Number: K781610 · 1978-10-24

ApplicantFisher Scientific Co., LLC
Decision Date1978-10-24
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BILIRUBIN DETERMINTAITON IN SERUM is the device name listed in this FDA 510(k) record. The listed applicant is Fisher Scientific Co., LLC. It received FDA 510(k) clearance on 1978-10-24 under 510(k) number K781610. 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 DETERMINTAITON IN SERUM?

BILIRUBIN DETERMINTAITON IN SERUM is a medical device that received FDA 510(k) clearance on 1978-10-24. The listed applicant is Fisher Scientific Co., LLC. The 510(k) number is K781610.

When did BILIRUBIN DETERMINTAITON IN SERUM receive FDA 510(k) clearance?

BILIRUBIN DETERMINTAITON IN SERUM received FDA 510(k) clearance on 1978-10-24, under 510(k) number K781610.

Who is the listed applicant for BILIRUBIN DETERMINTAITON IN SERUM?

The FDA 510(k) record lists Fisher Scientific Co., LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BILIRUBIN DETERMINTAITON IN SERUM?

The FDA product code for BILIRUBIN DETERMINTAITON IN SERUM is CIG.

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Other records listing Fisher Scientific Co., LLC 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.

K930415MICROHEMATOCRIT ROTORK915825MARATHON 6K GENERAL-PURPOSE CENTRIFUGEK915441MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGEK890534MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1K881275URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & IIK874054FISHER DIAGNOSTICS HEMATALL III LAS 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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