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FDA 510(k)

UBI MAGIWEL FERRITIN QUANTITATIVE

K-Number: K951993 · 1995-07-05

ApplicantUnited Biotech, Inc.
Decision Date1995-07-05
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

UBI MAGIWEL FERRITIN QUANTITATIVE is the device name listed in this FDA 510(k) record. The listed applicant is United Biotech, Inc.. It received FDA 510(k) clearance on 1995-07-05 under 510(k) number K951993. 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 UBI MAGIWEL FERRITIN QUANTITATIVE?

UBI MAGIWEL FERRITIN QUANTITATIVE is a medical device that received FDA 510(k) clearance on 1995-07-05. The listed applicant is United Biotech, Inc.. The 510(k) number is K951993.

When did UBI MAGIWEL FERRITIN QUANTITATIVE receive FDA 510(k) clearance?

UBI MAGIWEL FERRITIN QUANTITATIVE received FDA 510(k) clearance on 1995-07-05, under 510(k) number K951993.

Who is the listed applicant for UBI MAGIWEL FERRITIN QUANTITATIVE?

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

What is the FDA product code for UBI MAGIWEL FERRITIN QUANTITATIVE?

The FDA product code for UBI MAGIWEL FERRITIN QUANTITATIVE is DBF.

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Other records listing United 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.

K981573UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVEK973154UBI MAGIWEL MARIJUANA METABOLITESK973692UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVEK973156UBI MAGIWEL COCAINE METABOLITESK973155UBI MAGIWEL OPIATE METABOLITESK973153UBI MAGIWEL AMPHETAMINE METABOLITES

View all 22 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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