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FDA 510(k)

UNICAP THYROGLOBULIN IGG ASSAY, UNICAP THYROID PEROXIDASE IGG ASSAY

K-Number: K981559 · 1998-07-07

ApplicantPharmacia & Upjohn Co.
Decision Date1998-07-07
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

UNICAP THYROGLOBULIN IGG ASSAY, UNICAP THYROID PEROXIDASE IGG ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Pharmacia & Upjohn Co.. It received FDA 510(k) clearance on 1998-07-07 under 510(k) number K981559. The device is classified under product code JZO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNICAP THYROGLOBULIN IGG ASSAY, UNICAP THYROID PEROXIDASE IGG ASSAY?

UNICAP THYROGLOBULIN IGG ASSAY, UNICAP THYROID PEROXIDASE IGG ASSAY is a medical device that received FDA 510(k) clearance on 1998-07-07. The listed applicant is Pharmacia & Upjohn Co.. The 510(k) number is K981559.

When did UNICAP THYROGLOBULIN IGG ASSAY, UNICAP THYROID PEROXIDASE IGG ASSAY receive FDA 510(k) clearance?

UNICAP THYROGLOBULIN IGG ASSAY, UNICAP THYROID PEROXIDASE IGG ASSAY received FDA 510(k) clearance on 1998-07-07, under 510(k) number K981559.

Who is the listed applicant for UNICAP THYROGLOBULIN IGG ASSAY, UNICAP THYROID PEROXIDASE IGG ASSAY?

The FDA 510(k) record lists Pharmacia & Upjohn Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNICAP THYROGLOBULIN IGG ASSAY, UNICAP THYROID PEROXIDASE IGG ASSAY?

The FDA product code for UNICAP THYROGLOBULIN IGG ASSAY, UNICAP THYROID PEROXIDASE IGG ASSAY is JZO.

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Other records listing Pharmacia & Upjohn Co. as applicant

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K003414VARELISA TG (THYROGLOBULIN) ANTIBODIES,K002556CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1K000312VARELISA SM ANTIBODIESK000132ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10, FX16, FX73, I72, I75, I76, K71, K73, K81, K8K993585VARELISA TPO ANTIBODIES, MODEL 12348/12396K993388ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59, F60, F61, F205, F213, F218, F

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Related Devices (Code: JZO)

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K250250ADVIA Centaur Anti-Thyroid Peroxidase IISiemens Healthcare Diagnostics, Inc.K240469Access TPO AntibodyBeckman Coulter, Inc.K213517Access Thyroglobulin Antibody IIBeckman Coulter, Inc.K222610Elecsys Anti-TgRoche DiagnosticsK193313Elecsys Anti-TSHRRoche DiagnosticsK151799EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000Phadia AB

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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