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FDA 510(k)

KLEENASEPTIC

K-Number: K981023 · 1998-04-30

ApplicantMetrex Research Corp.
Decision Date1998-04-30
Product CodeLRJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

KLEENASEPTIC is the device name listed in this FDA 510(k) record. The listed applicant is Metrex Research Corp.. It received FDA 510(k) clearance on 1998-04-30 under 510(k) number K981023. 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 KLEENASEPTIC?

KLEENASEPTIC is a medical device that received FDA 510(k) clearance on 1998-04-30. The listed applicant is Metrex Research Corp.. The 510(k) number is K981023.

When did KLEENASEPTIC receive FDA 510(k) clearance?

KLEENASEPTIC received FDA 510(k) clearance on 1998-04-30, under 510(k) number K981023.

Who is the listed applicant for KLEENASEPTIC?

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

What is the FDA product code for KLEENASEPTIC?

The FDA product code for KLEENASEPTIC is LRJ. This falls under the Clinical Lab category.

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 Metrex Research 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.

K950553COLDCIDE-2K950516COLDCIDE-10K931052METRICIDE 28K931592METRICIDE PLUS 30 LIQUID CHEMICAL GERMICIDEK930284METRICIDE

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

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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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