FDA.reportPublic FDA data

ISOPURE, CORP.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30037680323013942511ISOPURE, CORP.1Y2026-01-0112500 Westport Rd. 12540 Westport Rd. Louisville KY US 40245

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
577951623618636K993200MD 420/440/460/470/480/490FIP2000-01-24
577951017055910K863720HD-100 HEMODIALYSIS SYSTEMS AND ACCESSORIESFIP1986-10-29
577951978758813K191093Isopure Dry Acid Dissolution SystemKPO2020-01-22
577951812943709K120005ACDSKPO2012-03-29
577951160171753K112427BICARB MIXING AND DISTRIBUTION SYSTEMFIN2012-01-26
577951594442917K041163ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIESFIP2004-10-07

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FIP32004-10-07
KPO22020-01-22
FIN12012-01-26

PMN#

ACDS

2012-03-29

ISOPURE CORP.

GUDID#