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FDA 510(k)

IRMA-COUNT FERRITIN W/MONO. ANTIBODIES RKFE1,2,5

K-Number: K874031 · 1987-11-25

ApplicantDiagnostic Products Corp.
Decision Date1987-11-25
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IRMA-COUNT FERRITIN W/MONO. ANTIBODIES RKFE1,2,5 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Products Corp.. It received FDA 510(k) clearance on 1987-11-25 under 510(k) number K874031. 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 IRMA-COUNT FERRITIN W/MONO. ANTIBODIES RKFE1,2,5?

IRMA-COUNT FERRITIN W/MONO. ANTIBODIES RKFE1,2,5 is a medical device that received FDA 510(k) clearance on 1987-11-25. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K874031.

When did IRMA-COUNT FERRITIN W/MONO. ANTIBODIES RKFE1,2,5 receive FDA 510(k) clearance?

IRMA-COUNT FERRITIN W/MONO. ANTIBODIES RKFE1,2,5 received FDA 510(k) clearance on 1987-11-25, under 510(k) number K874031.

Who is the listed applicant for IRMA-COUNT FERRITIN W/MONO. ANTIBODIES RKFE1,2,5?

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

What is the FDA product code for IRMA-COUNT FERRITIN W/MONO. ANTIBODIES RKFE1,2,5?

The FDA product code for IRMA-COUNT FERRITIN W/MONO. ANTIBODIES RKFE1,2,5 is DBF.

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Other records listing Diagnostic Products Corp. 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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