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FDA 510(k)

MULTICHEM (R) TOTAL BILIRUBIN

K-Number: K874311 · 1987-11-25

ApplicantSimmler, Inc.
Decision Date1987-11-25
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MULTICHEM (R) TOTAL BILIRUBIN is the device name listed in this FDA 510(k) record. The listed applicant is Simmler, Inc.. It received FDA 510(k) clearance on 1987-11-25 under 510(k) number K874311. 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 MULTICHEM (R) TOTAL BILIRUBIN?

MULTICHEM (R) TOTAL BILIRUBIN is a medical device that received FDA 510(k) clearance on 1987-11-25. The listed applicant is Simmler, Inc.. The 510(k) number is K874311.

When did MULTICHEM (R) TOTAL BILIRUBIN receive FDA 510(k) clearance?

MULTICHEM (R) TOTAL BILIRUBIN received FDA 510(k) clearance on 1987-11-25, under 510(k) number K874311.

Who is the listed applicant for MULTICHEM (R) TOTAL BILIRUBIN?

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

What is the FDA product code for MULTICHEM (R) TOTAL BILIRUBIN?

The FDA product code for MULTICHEM (R) TOTAL BILIRUBIN is CIG.

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Other records listing Simmler, 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.

K895745SICKLE CELL SOLUBILITY TEST KITK874903MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT)K874595MULTICHEM (R) MAGNESIUM REAGENTK874820MULTICHEM HDL PRECIPITATING REAGENT #S0914K874812MULTICHEM CHLORIDE REAGENT S0933K874049MULTICHEM ALBUMIN REAGENT S0902

View all 23 devices →

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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