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)

DIGOXIN RADIOIMMUNOASSAY KIT

K-Number: K801202 · 1980-06-20

ApplicantTechnia Diagnostics , Ltd.
Decision Date1980-06-20
Product CodeLCS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DIGOXIN RADIOIMMUNOASSAY 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 1980-06-20 under 510(k) number K801202. The device is classified under product code LCS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGOXIN RADIOIMMUNOASSAY KIT?

DIGOXIN RADIOIMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1980-06-20. The listed applicant is Technia Diagnostics , Ltd.. The 510(k) number is K801202.

When did DIGOXIN RADIOIMMUNOASSAY KIT receive FDA 510(k) clearance?

DIGOXIN RADIOIMMUNOASSAY KIT received FDA 510(k) clearance on 1980-06-20, under 510(k) number K801202.

Who is the listed applicant for DIGOXIN RADIOIMMUNOASSAY 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 DIGOXIN RADIOIMMUNOASSAY KIT?

The FDA product code for DIGOXIN RADIOIMMUNOASSAY KIT is LCS.

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 KITK801203CORTISOL RADIOIMMUNOASSAY KITK791361T3 UPTAKE RADIOIMMUNOASSAY KITK790919HPL RIA KITK790495THYROXINE RIA KIT

View all 9 devices →

Related Devices (Code: LCS)

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.

K922353DIGOXIN COATED TUBE RIAMonobindK913562QMS - DIGOXINSeradyn, Inc.K895828INNOFLUOR DIGOXIN REAGENT SETInnotron of Oregon, Inc.K884707FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KITCyberfluor, Inc.K874748IMMPULSE DIGOXIN ASSAY REAGENTSSclavo, Inc.K864802DART DIGOXIN ASSAYCoulter Electronics, 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.

↑