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FDA 510(k)

VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY

K-Number: K920952 · 1992-04-07

ApplicantVitek Systems, Inc.
Decision Date1992-04-07
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Vitek Systems, Inc.. It received FDA 510(k) clearance on 1992-04-07 under 510(k) number K920952. 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 VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY?

VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY is a medical device that received FDA 510(k) clearance on 1992-04-07. The listed applicant is Vitek Systems, Inc.. The 510(k) number is K920952.

When did VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY receive FDA 510(k) clearance?

VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY received FDA 510(k) clearance on 1992-04-07, under 510(k) number K920952.

Who is the listed applicant for VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY?

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

What is the FDA product code for VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY?

The FDA product code for VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY is DBF.

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Other records listing Vitek Systems, Inc. as applicant

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K920661VIDAS CMV IGG ASSAYK921302VITEK IMMUNODIAGNOSTIC ASSAY SYSTEMK921176VITEK IMMUNODIAGNOSTIC ASSAY SYSTEMK915884VIDAS CHLAMYDIA ASSAY, MODIFICATIONK905211VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAYK912371BIOMERIEUX RSV DIRECT IF KIT

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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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