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)

I-125 LABELED DIGOXIN

K-Number: K803047 · 1980-12-22

ApplicantPcl-Ria, Inc.
Decision Date1980-12-22
Product CodeLCS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

I-125 LABELED DIGOXIN is the device name listed in this FDA 510(k) record. The listed applicant is Pcl-Ria, Inc.. It received FDA 510(k) clearance on 1980-12-22 under 510(k) number K803047. 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 I-125 LABELED DIGOXIN?

I-125 LABELED DIGOXIN is a medical device that received FDA 510(k) clearance on 1980-12-22. The listed applicant is Pcl-Ria, Inc.. The 510(k) number is K803047.

When did I-125 LABELED DIGOXIN receive FDA 510(k) clearance?

I-125 LABELED DIGOXIN received FDA 510(k) clearance on 1980-12-22, under 510(k) number K803047.

Who is the listed applicant for I-125 LABELED DIGOXIN?

The FDA 510(k) record lists Pcl-Ria, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I-125 LABELED DIGOXIN?

The FDA product code for I-125 LABELED DIGOXIN 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 Pcl-Ria, Inc. 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.

K830526B-GCG SYSTEM BY RIAK822935THYROID STIMULATING HORMONEK823014DIGOXIN KITK822612T3 UPTAKE KITSK820886THYROXINE T4 KITK820358FOLLICLE STIMULATING HORMONE KIT

View all 29 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.

↑