Isopure Corp

FDA Filings

This page includes the latest FDA filings for Isopure Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3003768032
FEI Number3013942511
NameISOPURE CORP.
Owner & OperatorISOPURE CORP.
Contact Address11851 Plantside Drive --
Louisville KY 40299 US
Official Correspondent
  • KEVIN C GILLESPIE
  • x-502-9076634-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address11851 Plantside Drive
Louisville, KY 40299 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Isopure, Corp.
Acid Dissolution System 2024-02-22
Isopure, Corp.
Acid Dissolution System 2024-02-22
Isopure, Corp.
Isopure Dry Acid Dissolution System2020-01-22
ISOPURE, CORP.
Acidified Concentrate Distribution and Storage (ACDS) System 2018-07-06
ISOPURE, CORP.
Sodium Bicarbonate Mixing and Distribution System 2018-07-06
ISOPURE, CORP.
Complete Water Treatment System 2018-07-06
ISOPURE, CORP.
MD490 Reverse Osmosis System 2018-07-06
ISOPURE, CORP.
MD480 Reverse Osmosis System 2018-07-06
ISOPURE, CORP.
MD470 Reverse Osmosis System 2018-07-06
ISOPURE, CORP.
MD460 Reverse Osmosis System 2018-07-06
ISOPURE, CORP.
MD440 Reverse Osmosis System 2018-07-06
ISOPURE, CORP.
MD420 Reverse Osmosis System 2018-07-06
ISOPURE CORP.
Isopure ACDS (Acidified Concentrate Distribution and Storage)2012-12-13
ISOPURE CORP.
ACDS2012-03-29
ISOPURE CORP.
Isopure Sodium Bicarbonate Mixing and Distribution System2012-01-30
ISOPURE CORP.
BICARB MIXING AND DISTRIBUTION SYSTEM2012-01-26
ISOPURE CORP.
MD420/440/460/470/480/490 Reverse O2008-12-01
ISOPURE CORP.
MD-100 Mobile Water Purification Sy2008-12-01
ISOPURE CORP.
Isopure Complete Water System for H2007-10-09
ISOPURE CORP.
Isocube2007-10-09
ISOPURE CORP.
ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES2004-10-07
ISOPURE CORP.
MD 420/440/460/470/480/4902000-01-24

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