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FDA 510(k)

NEONATAL BILIRUBIN REAGENT

K-Number: K840779 · 1984-04-13

ApplicantAmerican Dade
Decision Date1984-04-13
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NEONATAL BILIRUBIN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1984-04-13 under 510(k) number K840779. 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 NEONATAL BILIRUBIN REAGENT?

NEONATAL BILIRUBIN REAGENT is a medical device that received FDA 510(k) clearance on 1984-04-13. The listed applicant is American Dade. The 510(k) number is K840779.

When did NEONATAL BILIRUBIN REAGENT receive FDA 510(k) clearance?

NEONATAL BILIRUBIN REAGENT received FDA 510(k) clearance on 1984-04-13, under 510(k) number K840779.

Who is the listed applicant for NEONATAL BILIRUBIN REAGENT?

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

What is the FDA product code for NEONATAL BILIRUBIN REAGENT?

The FDA product code for NEONATAL BILIRUBIN REAGENT is CIG.

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Other records listing American Dade 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.

K873051STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAYK873171STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYK873052STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAYK872789PARAMAX URINE/CSF CALIBRATORK872195DATA-FI DIMERTEST LATEX ASSAYK872196AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III

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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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