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FDA 510(k)

ALPCO MILENIA ANTI-TG EIA

K-Number: K011415 · 2001-05-30

ApplicantAmerican Laboratory Products Co., Ltd.
Decision Date2001-05-30
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ALPCO MILENIA ANTI-TG EIA 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 2001-05-30 under 510(k) number K011415. 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 ALPCO MILENIA ANTI-TG EIA?

ALPCO MILENIA ANTI-TG EIA is a medical device that received FDA 510(k) clearance on 2001-05-30. The listed applicant is American Laboratory Products Co., Ltd.. The 510(k) number is K011415.

When did ALPCO MILENIA ANTI-TG EIA receive FDA 510(k) clearance?

ALPCO MILENIA ANTI-TG EIA received FDA 510(k) clearance on 2001-05-30, under 510(k) number K011415.

Who is the listed applicant for ALPCO MILENIA ANTI-TG EIA?

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 ALPCO MILENIA ANTI-TG EIA?

The FDA product code for ALPCO MILENIA ANTI-TG EIA is JZO.

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Other records listing American Laboratory Products Co., Ltd. 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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