Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Elecsys Anti-TSHR

K-Number: K193313 · 2020-02-27

ApplicantRoche Diagnostics
Decision Date2020-02-27
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Elecsys Anti-TSHR is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2020-02-27 under 510(k) number K193313. 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 Elecsys Anti-TSHR?

Elecsys Anti-TSHR is a medical device that received FDA 510(k) clearance on 2020-02-27. The listed applicant is Roche Diagnostics. The 510(k) number is K193313.

When did Elecsys Anti-TSHR receive FDA 510(k) clearance?

Elecsys Anti-TSHR received FDA 510(k) clearance on 2020-02-27, under 510(k) number K193313.

Who is the listed applicant for Elecsys Anti-TSHR?

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

What is the FDA product code for Elecsys Anti-TSHR?

The FDA product code for Elecsys Anti-TSHR is JZO.

Other records listing Roche Diagnostics 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.

K252323cobas pulse blood glucose monitoring systemPMA P990056Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancerPMA P000027PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERSK252431Elecsys CalcitoninK252280Elecsys Anti-SARS-CoV-2 SK260049Elecsys Anti-HBc IgM

View all 84 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 DiagnosticsK151799EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000Phadia ABK152061IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc.

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.

↑