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)

HAEMOLYTE SOLUTION

K-Number: K831409 · 1983-06-30

ApplicantDialysis Clinic, Inc.
Decision Date1983-06-30
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HAEMOLYTE SOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Dialysis Clinic, Inc.. It received FDA 510(k) clearance on 1983-06-30 under 510(k) number K831409. The device is classified under product code KOC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HAEMOLYTE SOLUTION?

HAEMOLYTE SOLUTION is a medical device that received FDA 510(k) clearance on 1983-06-30. The listed applicant is Dialysis Clinic, Inc.. The 510(k) number is K831409.

When did HAEMOLYTE SOLUTION receive FDA 510(k) clearance?

HAEMOLYTE SOLUTION received FDA 510(k) clearance on 1983-06-30, under 510(k) number K831409.

Who is the listed applicant for HAEMOLYTE SOLUTION?

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

What is the FDA product code for HAEMOLYTE SOLUTION?

The FDA product code for HAEMOLYTE SOLUTION is KOC.

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

Related Devices (Code: KOC)

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.

K242479BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PUNIKKISO CO., LTD.K242176BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)NIKKISO CO., LTD.K231589Blood Tubing Lines for Hemodialysis AV06C-ENIKKISO CO., LTD.K230514Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 SeriesNIKKISO CO., LTD.K201207CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin LineFresenius Medical Care Renal Therapies Group, LLCK172238CAREline Airless Hemodialysis Blood Tubing SetsFresenius Medical Care Renal Therapies Group, LLC

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.

↑