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FDA 510(k)

PACKETS FOR THE PREP OF DIALYSATES &

K-Number: K842154 · 1984-07-31

ApplicantOrganon Teknika Corp.
Decision Date1984-07-31
Product CodeFKQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PACKETS FOR THE PREP OF DIALYSATES & is the device name listed in this FDA 510(k) record. The listed applicant is Organon Teknika Corp.. It received FDA 510(k) clearance on 1984-07-31 under 510(k) number K842154. 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 PACKETS FOR THE PREP OF DIALYSATES &?

PACKETS FOR THE PREP OF DIALYSATES & is a medical device that received FDA 510(k) clearance on 1984-07-31. The listed applicant is Organon Teknika Corp.. The 510(k) number is K842154.

When did PACKETS FOR THE PREP OF DIALYSATES & receive FDA 510(k) clearance?

PACKETS FOR THE PREP OF DIALYSATES & received FDA 510(k) clearance on 1984-07-31, under 510(k) number K842154.

Who is the listed applicant for PACKETS FOR THE PREP OF DIALYSATES &?

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

What is the FDA product code for PACKETS FOR THE PREP OF DIALYSATES &?

The FDA product code for PACKETS FOR THE PREP OF DIALYSATES & is FKQ.

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Other records listing Organon Teknika Corp. 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.

K003104BACT/ALERT CSRK000492MDA D-DIMERK000378BACT/ALERT MB CULTURE BOTTLEK994343BACT/ALERT SVK993423BACT/ALERT SAK993421BACT/ALERT SN

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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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