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FDA 510(k)

TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAY

K-Number: K863345 · 1986-10-08

ApplicantHybritech, Inc.
Decision Date1986-10-08
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Hybritech, Inc.. It received FDA 510(k) clearance on 1986-10-08 under 510(k) number K863345. 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 TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAY?

TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAY is a medical device that received FDA 510(k) clearance on 1986-10-08. The listed applicant is Hybritech, Inc.. The 510(k) number is K863345.

When did TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAY receive FDA 510(k) clearance?

TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAY received FDA 510(k) clearance on 1986-10-08, under 510(k) number K863345.

Who is the listed applicant for TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAY?

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

What is the FDA product code for TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAY?

The FDA product code for TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAY is DBF.

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Other records listing Hybritech, 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.

K972666TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAYK961573TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAYK930810TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAYK922754TANDEM-E IGE II CALIBRATION VERIFICATION SETK921745HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNOK921252TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL

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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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