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FDA 510(k)

BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY

K-Number: K982714 · 1998-10-22

ApplicantBayer Corp.
Decision Date1998-10-22
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Corp.. It received FDA 510(k) clearance on 1998-10-22 under 510(k) number K982714. 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 BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY?

BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY is a medical device that received FDA 510(k) clearance on 1998-10-22. The listed applicant is Bayer Corp.. The 510(k) number is K982714.

When did BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY receive FDA 510(k) clearance?

BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY received FDA 510(k) clearance on 1998-10-22, under 510(k) number K982714.

Who is the listed applicant for BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY?

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

What is the FDA product code for BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY?

The FDA product code for BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY is DBF.

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Other records listing Bayer Corp. 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.

K024062ASCENSIA BREEZE BLOOD GLUCOSE METERK023944BAYER DIAGNOSTICS CLINITEST PREGNANCY TESTK024017BAYER ADVIA CENTAUR HER-2/NEU ASSAYK024234ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONALK022288COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEMK023584ASCENSIA DEX 2 DIABETES CARE SYSTEM

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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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