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FDA 510(k)

ANTISERA TO HUMAN FERRITIN

K-Number: K822472 · 1982-09-30

ApplicantKent Laboratories, Inc.
Decision Date1982-09-30
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTISERA TO HUMAN FERRITIN is the device name listed in this FDA 510(k) record. The listed applicant is Kent Laboratories, Inc.. It received FDA 510(k) clearance on 1982-09-30 under 510(k) number K822472. 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 ANTISERA TO HUMAN FERRITIN?

ANTISERA TO HUMAN FERRITIN is a medical device that received FDA 510(k) clearance on 1982-09-30. The listed applicant is Kent Laboratories, Inc.. The 510(k) number is K822472.

When did ANTISERA TO HUMAN FERRITIN receive FDA 510(k) clearance?

ANTISERA TO HUMAN FERRITIN received FDA 510(k) clearance on 1982-09-30, under 510(k) number K822472.

Who is the listed applicant for ANTISERA TO HUMAN FERRITIN?

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

What is the FDA product code for ANTISERA TO HUMAN FERRITIN?

The FDA product code for ANTISERA TO HUMAN FERRITIN is DBF.

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Other records listing Kent Laboratories, Inc. 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.

K951966HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KITK951968HUMAN C1Q RADIAL IMMUNODIFFUSION KITK951967HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KITK950102HUMAN C-5 RADIAL IMMUNODIFFUSION KITK85068372 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2K85068272 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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