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FDA 510(k)

ELEGANCE FERRITIN ELISA

K-Number: K904822 · 1990-11-29

ApplicantBioclone Australia Pty , Ltd.
Decision Date1990-11-29
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ELEGANCE FERRITIN ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Bioclone Australia Pty , Ltd.. It received FDA 510(k) clearance on 1990-11-29 under 510(k) number K904822. 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 ELEGANCE FERRITIN ELISA?

ELEGANCE FERRITIN ELISA is a medical device that received FDA 510(k) clearance on 1990-11-29. The listed applicant is Bioclone Australia Pty , Ltd.. The 510(k) number is K904822.

When did ELEGANCE FERRITIN ELISA receive FDA 510(k) clearance?

ELEGANCE FERRITIN ELISA received FDA 510(k) clearance on 1990-11-29, under 510(k) number K904822.

Who is the listed applicant for ELEGANCE FERRITIN ELISA?

The FDA 510(k) record lists Bioclone Australia Pty , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELEGANCE FERRITIN ELISA?

The FDA product code for ELEGANCE FERRITIN ELISA is DBF.

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Other records listing Bioclone Australia Pty , Ltd. 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.

K935049ELEGANCE NEONATAL TSH ELISAK922284ELEGANCE FT4 ELISAK910419BIOCLONE'S ELEGANCE IGE ELISA KITK910420BIOCLONE'S ELEGANCE HCG ELISA KITK905099ELEGANCE TSH ELISAK905098ELEGANCE GH ELISA

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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

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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