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FDA 510(k)

LEECO FERRITIN-QUANT DIAG. TEST KIT

K-Number: K811880 · 1981-07-16

ApplicantLeeco Diagnostics, Inc.
Decision Date1981-07-16
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

LEECO FERRITIN-QUANT DIAG. TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Leeco Diagnostics, Inc.. It received FDA 510(k) clearance on 1981-07-16 under 510(k) number K811880. 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 LEECO FERRITIN-QUANT DIAG. TEST KIT?

LEECO FERRITIN-QUANT DIAG. TEST KIT is a medical device that received FDA 510(k) clearance on 1981-07-16. The listed applicant is Leeco Diagnostics, Inc.. The 510(k) number is K811880.

When did LEECO FERRITIN-QUANT DIAG. TEST KIT receive FDA 510(k) clearance?

LEECO FERRITIN-QUANT DIAG. TEST KIT received FDA 510(k) clearance on 1981-07-16, under 510(k) number K811880.

Who is the listed applicant for LEECO FERRITIN-QUANT DIAG. TEST KIT?

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

What is the FDA product code for LEECO FERRITIN-QUANT DIAG. TEST KIT?

The FDA product code for LEECO FERRITIN-QUANT DIAG. TEST KIT is DBF.

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Other records listing Leeco 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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