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FDA 510(k)

AMERLITE FERRITIN II ASSAY

K-Number: K952286 · 1995-06-20

ApplicantJohnson & Johnson Clinical Diagnostics, Inc.
Decision Date1995-06-20
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AMERLITE FERRITIN II ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Clinical Diagnostics, Inc.. It received FDA 510(k) clearance on 1995-06-20 under 510(k) number K952286. 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 AMERLITE FERRITIN II ASSAY?

AMERLITE FERRITIN II ASSAY is a medical device that received FDA 510(k) clearance on 1995-06-20. The listed applicant is Johnson & Johnson Clinical Diagnostics, Inc.. The 510(k) number is K952286.

When did AMERLITE FERRITIN II ASSAY receive FDA 510(k) clearance?

AMERLITE FERRITIN II ASSAY received FDA 510(k) clearance on 1995-06-20, under 510(k) number K952286.

Who is the listed applicant for AMERLITE FERRITIN II ASSAY?

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

What is the FDA product code for AMERLITE FERRITIN II ASSAY?

The FDA product code for AMERLITE FERRITIN II ASSAY is DBF.

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Other records listing Johnson & Johnson Clinical Diagnostics, Inc. as applicant

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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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