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 COATED TUBE RIA

K-Number: K922353 · 1992-08-24

ApplicantMonobind
Decision Date1992-08-24
Product CodeLCS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DIGOXIN COATED TUBE RIA is the device name listed in this FDA 510(k) record. The listed applicant is Monobind. It received FDA 510(k) clearance on 1992-08-24 under 510(k) number K922353. 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 COATED TUBE RIA?

DIGOXIN COATED TUBE RIA is a medical device that received FDA 510(k) clearance on 1992-08-24. The listed applicant is Monobind. The 510(k) number is K922353.

When did DIGOXIN COATED TUBE RIA receive FDA 510(k) clearance?

DIGOXIN COATED TUBE RIA received FDA 510(k) clearance on 1992-08-24, under 510(k) number K922353.

Who is the listed applicant for DIGOXIN COATED TUBE RIA?

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

What is the FDA product code for DIGOXIN COATED TUBE RIA?

The FDA product code for DIGOXIN COATED TUBE RIA 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 Monobind 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.

K030860ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300K020548FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300K980088T-UPTAKE MICROPLATE EIAK972720FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)K971834ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISAK971835ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA

View all 21 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.

K913562QMS - 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.K820154TDX DIGOXINAbbott 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.

↑