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FDA 510(k)

VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340)

K-Number: K973331 · 1997-10-22

ApplicantOrtho-Clinical Diagnostics, Inc.
Decision Date1997-10-22
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340) is the device name listed in this FDA 510(k) record. The listed applicant is Ortho-Clinical Diagnostics, Inc.. It received FDA 510(k) clearance on 1997-10-22 under 510(k) number K973331. 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 VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340)?

VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340) is a medical device that received FDA 510(k) clearance on 1997-10-22. The listed applicant is Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K973331.

When did VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340) receive FDA 510(k) clearance?

VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340) received FDA 510(k) clearance on 1997-10-22, under 510(k) number K973331.

Who is the listed applicant for VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340)?

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

What is the FDA product code for VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340)?

The FDA product code for VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340) is DBF.

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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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