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)

HEMODIALYSIS BATH CONCENTRATE SOLUTION

K-Number: K842058 · 1984-07-26

ApplicantPharmaceutical Development Systems
Decision Date1984-07-26
Product CodeFKQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HEMODIALYSIS BATH CONCENTRATE SOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Pharmaceutical Development Systems. It received FDA 510(k) clearance on 1984-07-26 under 510(k) number K842058. The device is classified under product code FKQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMODIALYSIS BATH CONCENTRATE SOLUTION?

HEMODIALYSIS BATH CONCENTRATE SOLUTION is a medical device that received FDA 510(k) clearance on 1984-07-26. The listed applicant is Pharmaceutical Development Systems. The 510(k) number is K842058.

When did HEMODIALYSIS BATH CONCENTRATE SOLUTION receive FDA 510(k) clearance?

HEMODIALYSIS BATH CONCENTRATE SOLUTION received FDA 510(k) clearance on 1984-07-26, under 510(k) number K842058.

Who is the listed applicant for HEMODIALYSIS BATH CONCENTRATE SOLUTION?

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

What is the FDA product code for HEMODIALYSIS BATH CONCENTRATE SOLUTION?

The FDA product code for HEMODIALYSIS BATH CONCENTRATE SOLUTION is FKQ.

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: FKQ)

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.

K052764DIACAP ULTRA DIALYSIS FLUID FILTERB. Braun Medizintechnologie GmbHK893612TWO TANK DISSOLUTION MODULENational Medical Care, Medical Products Div., Inc.K874084MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDMNational Medical Care, Medical Products Div., Inc.K873421KAWASUMI A.V. FISTULA SETKawasumi Laboratories Co., Ltd.K870889ACID FUCHSIN SOLUTIONSD.R.G. Scientific IndustriesK861730ACTRIL FOR KIDNEY MACHINE DISINFECTANTRenal Systems, 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.

↑