FDA 510(k)

LOW PH PHENOLIC 256

K-Number: K983585 · 1998-11-06

Decision Date1998-11-06

Product CodeLRJ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

LOW PH PHENOLIC 256 is the device name listed in this FDA 510(k) record. The listed applicant is Central Solutions, Inc.. It received FDA 510(k) clearance on 1998-11-06 under 510(k) number K983585. 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 LOW PH PHENOLIC 256?

LOW PH PHENOLIC 256 is a medical device that received FDA 510(k) clearance on 1998-11-06. The listed applicant is Central Solutions, Inc.. The 510(k) number is K983585.

When did LOW PH PHENOLIC 256 receive FDA 510(k) clearance?

LOW PH PHENOLIC 256 received FDA 510(k) clearance on 1998-11-06, under 510(k) number K983585.

Who is the listed applicant for LOW PH PHENOLIC 256?

The FDA 510(k) record lists Central Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LOW PH PHENOLIC 256?

The FDA product code for LOW PH PHENOLIC 256 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: LRJ)

K992661CONTROL III ELITEMaril Products, Inc.K991509PRO-PORTION CLEANER/DISINFECTANTSultan Chemists, Inc.K984485MICROSTAT 2Chemlink Laboratories, LLC K983947AMERSE 2STERIS Corporation K983869DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACHCaltech Industries, Inc.K982985CITREX HOSPITAL SPRAY DISINFECTANTCaltech Industries, 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.