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)

TECHNICON RA SYSTEM THYROXINE T4 METHOD

K-Number: K894575 · 1989-10-04

ApplicantTechnicon Instruments Corp.
Decision Date1989-10-04
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TECHNICON RA SYSTEM THYROXINE T4 METHOD is the device name listed in this FDA 510(k) record. The listed applicant is Technicon Instruments Corp.. It received FDA 510(k) clearance on 1989-10-04 under 510(k) number K894575. 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 TECHNICON RA SYSTEM THYROXINE T4 METHOD?

TECHNICON RA SYSTEM THYROXINE T4 METHOD is a medical device that received FDA 510(k) clearance on 1989-10-04. The listed applicant is Technicon Instruments Corp.. The 510(k) number is K894575.

When did TECHNICON RA SYSTEM THYROXINE T4 METHOD receive FDA 510(k) clearance?

TECHNICON RA SYSTEM THYROXINE T4 METHOD received FDA 510(k) clearance on 1989-10-04, under 510(k) number K894575.

Who is the listed applicant for TECHNICON RA SYSTEM THYROXINE T4 METHOD?

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

What is the FDA product code for TECHNICON RA SYSTEM THYROXINE T4 METHOD?

The FDA product code for TECHNICON RA SYSTEM THYROXINE T4 METHOD 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 Technicon Instruments 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.

K914888TECHNICON CHEM 1(TM) SYST (GEN2 SYST)K914511TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOLK914025TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P)K912616TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTESK912413CHEM-LINK DATA BASE MANAGERK903824DRUG OF ABUSE ANALYSIS SYSTEM FREE RADICAL ASSAY

View all 157 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.

↑