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)

KRONUS OPTIQUANT THYROGLOBULIN KIT

K-Number: K991720 · 1999-08-09

ApplicantUnchanged
Decision Date1999-08-09
Product CodeMSW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

KRONUS OPTIQUANT THYROGLOBULIN KIT is the device name listed in this FDA 510(k) record. The listed applicant is Unchanged. It received FDA 510(k) clearance on 1999-08-09 under 510(k) number K991720. The device is classified under product code MSW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KRONUS OPTIQUANT THYROGLOBULIN KIT?

KRONUS OPTIQUANT THYROGLOBULIN KIT is a medical device that received FDA 510(k) clearance on 1999-08-09. The listed applicant is Unchanged. The 510(k) number is K991720.

When did KRONUS OPTIQUANT THYROGLOBULIN KIT receive FDA 510(k) clearance?

KRONUS OPTIQUANT THYROGLOBULIN KIT received FDA 510(k) clearance on 1999-08-09, under 510(k) number K991720.

Who is the listed applicant for KRONUS OPTIQUANT THYROGLOBULIN KIT?

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

What is the FDA product code for KRONUS OPTIQUANT THYROGLOBULIN KIT?

The FDA product code for KRONUS OPTIQUANT THYROGLOBULIN KIT is MSW.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: MSW)

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.

K242981Atellica IM Thyroglobulin (Tg)Siemens Healthcare Diagnostics, Inc.K240927Access ThyroglobulinBeckman Coulter, Inc.K241423Access ThyroglobulinBeckman Coulter, Inc.K221890Elecsys Tg IIRoche DiagnosticsK220972Access ThyroglobulinBeckman Coulter, Inc.K031269ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMSBeckman Coulter, 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.

↑