FDA 510(k)

EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000

Numéro K : K151799 · 2016-03-25

Date de décision2016-03-25

Code produitJZO

Comité consultatifIM

DécisionSubstantially Equivalent

Résumé du dispositif

EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 is the device name listed in this FDA 510(k) record. The listed applicant is Phadia AB. It received FDA 510(k) clearance on 2016-03-25 under 510(k) number K151799. The device is classified under product code JZO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000?

EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 is a medical device that received FDA 510(k) clearance on 2016-03-25. The listed applicant is Phadia AB. The 510(k) number is K151799.

When did EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 receive FDA 510(k) clearance?

EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 received FDA 510(k) clearance on 2016-03-25, under 510(k) number K151799.

Who is the listed applicant for EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000?

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

What is the FDA product code for EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000?

The FDA product code for EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 is JZO.

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Autres dossiers indiquant Phadia AB en tant que demandeur

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Dispositifs connexes (Code : JZO)

K250250ADVIA Centaur Anti-Thyroid Peroxidase IISiemens Healthcare Diagnostics, Inc.K240469Access TPO AntibodyBeckman Coulter, Inc.K213517Access Thyroglobulin Antibody IIBeckman Coulter, Inc.K222610Elecsys Anti-TgRoche Diagnostics K193313Elecsys Anti-TSHRRoche Diagnostics K152061IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc.

Source officielle

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