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)

IMMULITE DIGOXIN

K-Number: K914833 · 1991-11-22

ApplicantCirrus Diagnostics, Inc.
Decision Date1991-11-22
Product CodeDPO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

IMMULITE DIGOXIN is the device name listed in this FDA 510(k) record. The listed applicant is Cirrus Diagnostics, Inc.. It received FDA 510(k) clearance on 1991-11-22 under 510(k) number K914833. The device is classified under product code DPO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMULITE DIGOXIN?

IMMULITE DIGOXIN is a medical device that received FDA 510(k) clearance on 1991-11-22. The listed applicant is Cirrus Diagnostics, Inc.. The 510(k) number is K914833.

When did IMMULITE DIGOXIN receive FDA 510(k) clearance?

IMMULITE DIGOXIN received FDA 510(k) clearance on 1991-11-22, under 510(k) number K914833.

Who is the listed applicant for IMMULITE DIGOXIN?

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

What is the FDA product code for IMMULITE DIGOXIN?

The FDA product code for IMMULITE DIGOXIN is DPO.

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 Cirrus Diagnostics, 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.

K921704IMMULITE(R) FSHK920411IMMULITE HLHK911796IMMULITE(TM) HCGK910677IMMULITE(TM) T-UPTAKEK910261IMMULITE(TM) TOTAL T4K905648CRP LIPID REAGENT TEST PACK

View all 10 devices →

Related Devices (Code: DPO)

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.

K905719ECLIPSE ICA DIGOXINBiotope, Inc.K864449DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KITCanadian Bioclinical, Ltd.K833842RIA COAT DIGOXINImmuno Assay Corp.K832163SOPHEIA DIGOXIN EIA KITDiagnostic Products Corp.K830962IMMUCHEM COVALENT-COAT RIA KITImmuchem Corp.K811932COAT-A-COUNT DIGOXIN RIADiagnostic Products Corp.

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.

↑