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FDA 510(k)

DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD

K-Number: K843963 · 1985-01-07

ApplicantRenal Systems, Inc.
Decision Date1985-01-07
Product CodeFKQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD is the device name listed in this FDA 510(k) record. The listed applicant is Renal Systems, Inc.. It received FDA 510(k) clearance on 1985-01-07 under 510(k) number K843963. 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 DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD?

DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD is a medical device that received FDA 510(k) clearance on 1985-01-07. The listed applicant is Renal Systems, Inc.. The 510(k) number is K843963.

When did DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD receive FDA 510(k) clearance?

DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD received FDA 510(k) clearance on 1985-01-07, under 510(k) number K843963.

Who is the listed applicant for DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD?

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

What is the FDA product code for DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD?

The FDA product code for DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD is FKQ.

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Other records listing Renal Systems, 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.

K970648PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S)K861730ACTRIL FOR KIDNEY MACHINE DISINFECTANTK854011RENALFO HEMOFILTER CAVHDK844790RENAFLO HEMOCONCENTRATORK844108RENAL SYSTEMS PERITONEAL ACCESS SYSTEMK842258RENATRON

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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.

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