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FDA 510(k)

TSH RECEPTOR ANTIBODY KIT 125I TSH

K-Number: K841580 · 1984-10-22

ApplicantClinetics Corp.
Decision Date1984-10-22
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TSH RECEPTOR ANTIBODY KIT 125I TSH is the device name listed in this FDA 510(k) record. The listed applicant is Clinetics Corp.. It received FDA 510(k) clearance on 1984-10-22 under 510(k) number K841580. 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 TSH RECEPTOR ANTIBODY KIT 125I TSH?

TSH RECEPTOR ANTIBODY KIT 125I TSH is a medical device that received FDA 510(k) clearance on 1984-10-22. The listed applicant is Clinetics Corp.. The 510(k) number is K841580.

When did TSH RECEPTOR ANTIBODY KIT 125I TSH receive FDA 510(k) clearance?

TSH RECEPTOR ANTIBODY KIT 125I TSH received FDA 510(k) clearance on 1984-10-22, under 510(k) number K841580.

Who is the listed applicant for TSH RECEPTOR ANTIBODY KIT 125I TSH?

The FDA 510(k) record lists Clinetics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TSH RECEPTOR ANTIBODY KIT 125I TSH?

The FDA product code for TSH RECEPTOR ANTIBODY KIT 125I TSH is JZO.

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Other records listing Clinetics Corp. 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.

K862180MODIFIED COTROPIN RADIOIMMUNOASSAY KITK844066COTROPIN STIMULATANEOUS 57 CO-LH 125I I-FSHK833934ADRENOCORTICOTROPIC HORMONE TESTK830357RADIOIMMUNOASSAY IMMUNOGLOBULINS D.EK823380125-I LH RADIOIMMUNOASSAY KITK823379125-I FSH RADIOIMMUNOASSAY KIT

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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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