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)

THYROXINE RIA KIT

K-Number: K790495 · 1979-05-03

ApplicantTechnia Diagnostics , Ltd.
Decision Date1979-05-03
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

THYROXINE RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Technia Diagnostics , Ltd.. It received FDA 510(k) clearance on 1979-05-03 under 510(k) number K790495. The device is classified under product code CDX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THYROXINE RIA KIT?

THYROXINE RIA KIT is a medical device that received FDA 510(k) clearance on 1979-05-03. The listed applicant is Technia Diagnostics , Ltd.. The 510(k) number is K790495.

When did THYROXINE RIA KIT receive FDA 510(k) clearance?

THYROXINE RIA KIT received FDA 510(k) clearance on 1979-05-03, under 510(k) number K790495.

Who is the listed applicant for THYROXINE RIA KIT?

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

What is the FDA product code for THYROXINE RIA KIT?

The FDA product code for THYROXINE RIA KIT is CDX.

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

Other records listing Technia Diagnostics , 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.

K861978AUTOFLUOR VK801843T3(125) RADIOIMMUNOASSAY KITK801202DIGOXIN RADIOIMMUNOASSAY KITK801203CORTISOL RADIOIMMUNOASSAY KITK791361T3 UPTAKE RADIOIMMUNOASSAY KITK790919HPL RIA KIT

View all 9 devices →

Related Devices (Code: CDX)

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.

K961490ELECSYS T4 ASSAYBoehringer Mannheim Corp.K954312ACTIVE THYROXINE RIADiagnostic Systems Laboratories, Inc.K943416DELFIA NEONATAL THYROXINE KITWallac OYK934384AXSYM(TM) TOTAL T4Abbott LaboratoriesK932980TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116Sigma Diagnostics, Inc.K933426STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNOBaxter 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.

↑