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FDA 510(k)

MODIFIED FERRITIN ENZYME IMMUNOASSAY TEST KIT

K-Number: K896585 · 1989-12-04

ApplicantMedix Biotech, Inc.
Decision Date1989-12-04
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MODIFIED FERRITIN ENZYME IMMUNOASSAY TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Medix Biotech, Inc.. It received FDA 510(k) clearance on 1989-12-04 under 510(k) number K896585. 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 MODIFIED FERRITIN ENZYME IMMUNOASSAY TEST KIT?

MODIFIED FERRITIN ENZYME IMMUNOASSAY TEST KIT is a medical device that received FDA 510(k) clearance on 1989-12-04. The listed applicant is Medix Biotech, Inc.. The 510(k) number is K896585.

When did MODIFIED FERRITIN ENZYME IMMUNOASSAY TEST KIT receive FDA 510(k) clearance?

MODIFIED FERRITIN ENZYME IMMUNOASSAY TEST KIT received FDA 510(k) clearance on 1989-12-04, under 510(k) number K896585.

Who is the listed applicant for MODIFIED FERRITIN ENZYME IMMUNOASSAY TEST KIT?

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

What is the FDA product code for MODIFIED FERRITIN ENZYME IMMUNOASSAY TEST KIT?

The FDA product code for MODIFIED FERRITIN ENZYME IMMUNOASSAY TEST KIT is DBF.

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Other records listing Medix Biotech, 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.

K952873MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION)K952319CONTRAST & RAPID HCG URINE/SERUM TSTK932482MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010K932758MEDIX BIOTECH BESTEST HCG-URINE TEST KITK925436MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KITK924259MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100

View all 39 devices →

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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