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FDA 510(k)

REAGENT, TOTAL BILIRUBIN DETERMINATION

K-Number: K760479 · 1976-10-29

ApplicantSimmler & Son, Inc.
Decision Date1976-10-29
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REAGENT, TOTAL BILIRUBIN DETERMINATION is the device name listed in this FDA 510(k) record. The listed applicant is Simmler & Son, Inc.. It received FDA 510(k) clearance on 1976-10-29 under 510(k) number K760479. 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 REAGENT, TOTAL BILIRUBIN DETERMINATION?

REAGENT, TOTAL BILIRUBIN DETERMINATION is a medical device that received FDA 510(k) clearance on 1976-10-29. The listed applicant is Simmler & Son, Inc.. The 510(k) number is K760479.

When did REAGENT, TOTAL BILIRUBIN DETERMINATION receive FDA 510(k) clearance?

REAGENT, TOTAL BILIRUBIN DETERMINATION received FDA 510(k) clearance on 1976-10-29, under 510(k) number K760479.

Who is the listed applicant for REAGENT, TOTAL BILIRUBIN DETERMINATION?

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

What is the FDA product code for REAGENT, TOTAL BILIRUBIN DETERMINATION?

The FDA product code for REAGENT, TOTAL BILIRUBIN DETERMINATION is CIG.

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Other records listing Simmler & Son, 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.

K780817GLOBIN-TERGEK771903LIPASEK771905GLYCEROL SUBSTRATEK771904GLYCEROL KINASEK771906PHOSPHATEK761086REAGENTS

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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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