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FDA 510(k)

BIOCHECK FERRITIN ELISA MODEL BC-1025

K-Number: K992517 · 1999-09-24

ApplicantBiocheck, Inc.
Decision Date1999-09-24
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

BIOCHECK FERRITIN ELISA MODEL BC-1025 is the device name listed in this FDA 510(k) record. The listed applicant is Biocheck, Inc.. It received FDA 510(k) clearance on 1999-09-24 under 510(k) number K992517. 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 BIOCHECK FERRITIN ELISA MODEL BC-1025?

BIOCHECK FERRITIN ELISA MODEL BC-1025 is a medical device that received FDA 510(k) clearance on 1999-09-24. The listed applicant is Biocheck, Inc.. The 510(k) number is K992517.

When did BIOCHECK FERRITIN ELISA MODEL BC-1025 receive FDA 510(k) clearance?

BIOCHECK FERRITIN ELISA MODEL BC-1025 received FDA 510(k) clearance on 1999-09-24, under 510(k) number K992517.

Who is the listed applicant for BIOCHECK FERRITIN ELISA MODEL BC-1025?

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

What is the FDA product code for BIOCHECK FERRITIN ELISA MODEL BC-1025?

The FDA product code for BIOCHECK FERRITIN ELISA MODEL BC-1025 is DBF.

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Other records listing Biocheck, 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.

K041619BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116K040030BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114K022660BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117K013062BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KITK003851BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119K002294BIOCHECK TESTOSTERONE EIA, MODEL BC-1115

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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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