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FDA 510(k)

NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY

K-Number: K984186 · 1999-02-02

ApplicantNichols Institute Diagnostics
Decision Date1999-02-02
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Nichols Institute Diagnostics. It received FDA 510(k) clearance on 1999-02-02 under 510(k) number K984186. The device is classified under product code DBF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY?

NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1999-02-02. The listed applicant is Nichols Institute Diagnostics. The 510(k) number is K984186.

When did NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY receive FDA 510(k) clearance?

NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY received FDA 510(k) clearance on 1999-02-02, under 510(k) number K984186.

Who is the listed applicant for NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY?

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

What is the FDA product code for NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY?

The FDA product code for NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY is DBF.

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Other records listing Nichols Institute Diagnostics 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.

K050784NICHOLS ADVANTAGE ALDOSTERONE ASSAYK042676NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAYK042689NICHOLS ADVANTAGE CORTISOLK040813NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022K033727NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAYK033302NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040

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Related Devices (Code: DBF)

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.

K193650LIAISON FerritinDiaSorin, Inc.K191562Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid FactorHORIBA ABX SASK171642Atellica IM Ferritin AssaySiemens Healthcare Diagnostics, Inc.K121232K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATORKamiya Biomedical CompanyK110736ADVIA CHEMISTRY FERRITIN (FRT) METHODSiemens Healthcare Diagnostics, Inc.K100538TINA-QUANT FERRITIN GEN. 4Roche Diagnostics

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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