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)

ENDAB DIGOXIN KIT

K-Number: K812054 · 1981-08-12

ApplicantImmunotech Corp.
Decision Date1981-08-12
Product CodeKXT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ENDAB DIGOXIN KIT is the device name listed in this FDA 510(k) record. The listed applicant is Immunotech Corp.. It received FDA 510(k) clearance on 1981-08-12 under 510(k) number K812054. The device is classified under product code KXT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDAB DIGOXIN KIT?

ENDAB DIGOXIN KIT is a medical device that received FDA 510(k) clearance on 1981-08-12. The listed applicant is Immunotech Corp.. The 510(k) number is K812054.

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

ENDAB DIGOXIN KIT received FDA 510(k) clearance on 1981-08-12, under 510(k) number K812054.

Who is the listed applicant for ENDAB DIGOXIN KIT?

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

What is the FDA product code for ENDAB DIGOXIN KIT?

The FDA product code for ENDAB DIGOXIN KIT is KXT.

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 Immunotech 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.

K954188OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROLK952789OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIESK950626OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIESK931228PROGESTERONE RADIOIMMUNOASSAY KITK911634MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TESTK911153MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT

View all 37 devices →

Related Devices (Code: KXT)

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.

K193397ADVIA Centaur® Digoxin assaySiemens Healthcare Diagnostics, Inc.K153301Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac IIRoche DiagnosticsK102346RANDOX DIGOXIN ASSAYRandox Laboratories, Ltd.K093441DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435Siemens Healthcare DiagnosticsK082953ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01Biokit, S.A.K061249AXSYM DIGOXIN IIIAbbott Laboratories

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.

↑