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FDA 510(k)

AIA-PACK TGAB ASSAY

K-Number: K981522 · 1998-10-08

ApplicantTosoh Medics, Inc.
Decision Date1998-10-08
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AIA-PACK TGAB ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Tosoh Medics, Inc.. It received FDA 510(k) clearance on 1998-10-08 under 510(k) number K981522. 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 AIA-PACK TGAB ASSAY?

AIA-PACK TGAB ASSAY is a medical device that received FDA 510(k) clearance on 1998-10-08. The listed applicant is Tosoh Medics, Inc.. The 510(k) number is K981522.

When did AIA-PACK TGAB ASSAY receive FDA 510(k) clearance?

AIA-PACK TGAB ASSAY received FDA 510(k) clearance on 1998-10-08, under 510(k) number K981522.

Who is the listed applicant for AIA-PACK TGAB ASSAY?

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

What is the FDA product code for AIA-PACK TGAB ASSAY?

The FDA product code for AIA-PACK TGAB ASSAY is JZO.

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Other records listing Tosoh Medics, Inc. as applicant

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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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