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FDA 510(k)

VARELISA TG (THYROGLOBULIN) ANTIBODIES,

K-Number: K003414 · 2000-11-27

ApplicantPharmacia & Upjohn Co.
Decision Date2000-11-27
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VARELISA TG (THYROGLOBULIN) ANTIBODIES, 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 2000-11-27 under 510(k) number K003414. 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 VARELISA TG (THYROGLOBULIN) ANTIBODIES,?

VARELISA TG (THYROGLOBULIN) ANTIBODIES, is a medical device that received FDA 510(k) clearance on 2000-11-27. The listed applicant is Pharmacia & Upjohn Co.. The 510(k) number is K003414.

When did VARELISA TG (THYROGLOBULIN) ANTIBODIES, receive FDA 510(k) clearance?

VARELISA TG (THYROGLOBULIN) ANTIBODIES, received FDA 510(k) clearance on 2000-11-27, under 510(k) number K003414.

Who is the listed applicant for VARELISA TG (THYROGLOBULIN) ANTIBODIES,?

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 VARELISA TG (THYROGLOBULIN) ANTIBODIES,?

The FDA product code for VARELISA TG (THYROGLOBULIN) ANTIBODIES, is JZO.

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Other records listing Pharmacia & Upjohn Co. 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.

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, FK993589VARELISA RNP ANTIBODIES

View all 18 devices →

Related Devices (Code: JZO)

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.

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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