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FDA 510(k)

RENALIN COLD STERILANT

K-Number: K882564 · 1989-01-09

ApplicantMinntech Corp.
Decision Date1989-01-09
Product CodeLRJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

RENALIN COLD STERILANT is the device name listed in this FDA 510(k) record. The listed applicant is Minntech Corp.. It received FDA 510(k) clearance on 1989-01-09 under 510(k) number K882564. The device is classified under product code LRJ. It was reviewed by the HO advisory panel. Product code LRJ falls under the category of Clinical Lab, which includes general clinical laboratory instruments. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RENALIN COLD STERILANT?

RENALIN COLD STERILANT is a medical device that received FDA 510(k) clearance on 1989-01-09. The listed applicant is Minntech Corp.. The 510(k) number is K882564.

When did RENALIN COLD STERILANT receive FDA 510(k) clearance?

RENALIN COLD STERILANT received FDA 510(k) clearance on 1989-01-09, under 510(k) number K882564.

Who is the listed applicant for RENALIN COLD STERILANT?

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

What is the FDA product code for RENALIN COLD STERILANT?

The FDA product code for RENALIN COLD STERILANT is LRJ. This falls under the Clinical Lab category.

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Other records listing Minntech 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.

K120306RAPICIDE OPA-28K092387MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEMK071298HF JUNIOR HEMOFILTERK050952HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATORK033505RENACLEAN SH DIALYZER CLEANING SYSTEMK014016ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER

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Related Devices (Code: LRJ)

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.

K992661CONTROL III ELITEMaril Products, Inc.K991509PRO-PORTION CLEANER/DISINFECTANTSultan Chemists, Inc.K984485MICROSTAT 2Chemlink Laboratories, LLCK983947AMERSE 2STERIS CorporationK983869DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACHCaltech Industries, Inc.K983585LOW PH PHENOLIC 256Central Solutions, 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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