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FDA 510(k)

T.B.Q. RTU

K-Number: K980369 · 1998-02-17

ApplicantSTERIS Corporation
Decision Date1998-02-17
Product CodeLRJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

T.B.Q. RTU is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 1998-02-17 under 510(k) number K980369. 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 T.B.Q. RTU?

T.B.Q. RTU is a medical device that received FDA 510(k) clearance on 1998-02-17. The listed applicant is STERIS Corporation. The 510(k) number is K980369.

When did T.B.Q. RTU receive FDA 510(k) clearance?

T.B.Q. RTU received FDA 510(k) clearance on 1998-02-17, under 510(k) number K980369.

Who is the listed applicant for T.B.Q. RTU?

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

What is the FDA product code for T.B.Q. RTU?

The FDA product code for T.B.Q. RTU is LRJ. This falls under the Clinical Lab category.

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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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