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FDA 510(k)

RENALIN (TENTATIVE

K-Number: K830575 · 1983-03-31

ApplicantRenal Systems, Inc.
Decision Date1983-03-31
Product CodeLIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RENALIN (TENTATIVE 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 1983-03-31 under 510(k) number K830575. The device is classified under product code LIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RENALIN (TENTATIVE?

RENALIN (TENTATIVE is a medical device that received FDA 510(k) clearance on 1983-03-31. The listed applicant is Renal Systems, Inc.. The 510(k) number is K830575.

When did RENALIN (TENTATIVE receive FDA 510(k) clearance?

RENALIN (TENTATIVE received FDA 510(k) clearance on 1983-03-31, under 510(k) number K830575.

Who is the listed applicant for RENALIN (TENTATIVE?

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 RENALIN (TENTATIVE?

The FDA product code for RENALIN (TENTATIVE is LIF.

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Other records listing Renal Systems, Inc. as applicant

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Related Devices (Code: LIF)

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.

K091360CLEARFLUX DIALYZER REPROCESSING SYSTEMNovaflux TechnologiesK043126ASSIST HEADER CLEANERAlcavis International, Inc.K040660STERICHEK GLUTARALDEHYDE REAGENT STRIPSHach CompanyK033505RENACLEAN SH DIALYZER CLEANING SYSTEMMinntech Corp.K024076MAKY 21.1 DIALYZER REPROCESSING SYSTEMHdc Maquinolas, LLCK013713ARM AUTOMATIC REPROCESSING MACHINEAlcavis International Incorporated

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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