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FDA 510(k)

HEMODIALYSIS CONCENTRATE

K-Number: K854391 · 1986-01-08

ApplicantDana Laboratories
Decision Date1986-01-08
Product CodeFKQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HEMODIALYSIS CONCENTRATE is the device name listed in this FDA 510(k) record. The listed applicant is Dana Laboratories. It received FDA 510(k) clearance on 1986-01-08 under 510(k) number K854391. 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 CONCENTRATE?

HEMODIALYSIS CONCENTRATE is a medical device that received FDA 510(k) clearance on 1986-01-08. The listed applicant is Dana Laboratories. The 510(k) number is K854391.

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

HEMODIALYSIS CONCENTRATE received FDA 510(k) clearance on 1986-01-08, under 510(k) number K854391.

Who is the listed applicant for HEMODIALYSIS CONCENTRATE?

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

What is the FDA product code for HEMODIALYSIS CONCENTRATE?

The FDA product code for HEMODIALYSIS CONCENTRATE 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.

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Other records listing Dana Laboratories 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.

K851431HEMODIALYSIS CONCENTRATE ADDITIVES

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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