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FDA 510(k)

ORGENTEC ANTI-TG/ANTI-TPO PIA (PIN IMMUNO ASSAY)

K-Number: K950088 · 1995-04-21

ApplicantAmerican Laboratory Products Co., Ltd.
Decision Date1995-04-21
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ORGENTEC ANTI-TG/ANTI-TPO PIA (PIN IMMUNO ASSAY) is the device name listed in this FDA 510(k) record. The listed applicant is American Laboratory Products Co., Ltd.. It received FDA 510(k) clearance on 1995-04-21 under 510(k) number K950088. 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 ORGENTEC ANTI-TG/ANTI-TPO PIA (PIN IMMUNO ASSAY)?

ORGENTEC ANTI-TG/ANTI-TPO PIA (PIN IMMUNO ASSAY) is a medical device that received FDA 510(k) clearance on 1995-04-21. The listed applicant is American Laboratory Products Co., Ltd.. The 510(k) number is K950088.

When did ORGENTEC ANTI-TG/ANTI-TPO PIA (PIN IMMUNO ASSAY) receive FDA 510(k) clearance?

ORGENTEC ANTI-TG/ANTI-TPO PIA (PIN IMMUNO ASSAY) received FDA 510(k) clearance on 1995-04-21, under 510(k) number K950088.

Who is the listed applicant for ORGENTEC ANTI-TG/ANTI-TPO PIA (PIN IMMUNO ASSAY)?

The FDA 510(k) record lists American Laboratory Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORGENTEC ANTI-TG/ANTI-TPO PIA (PIN IMMUNO ASSAY)?

The FDA product code for ORGENTEC ANTI-TG/ANTI-TPO PIA (PIN IMMUNO ASSAY) is JZO.

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Other records listing American Laboratory Products Co., Ltd. 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.

K012576CIC-C1Q EIAK011415ALPCO MILENIA ANTI-TG EIAK011201ALPCO MILENIA ANTI-TPO ELISAK974702ORGENTEC ANTI-PR3 (C-ANCA) ELISAK974701ORGENTEC ANTI-MPO (P-ANCA) ELISAK972190THYROGLOBULIN ASSAY SYSTEM

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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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