FDA.reportPublic FDA data

KPI Healthcare, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20900413002067630KPI Healthcare, INC.1Y2020-04-2523865 Via del RIo Yorba Linda CA US 92887

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
179631750762408K182286Oh'Care Lite Smart Blood Glucose Monitoring SystemNBW2018-09-19
179631404446091K132966GLUNEO LITE GLUCOSE MONITORING SYSTEM, GLUNEO LITE PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEMNBW2013-12-05
179631849450854K131457FETAL ULTRASONIC MONITOR AND ACCESSORIESKNG2014-01-24
179631377731809K131395TRANSTEK BLOOD PRESSURE MONITORDXN2013-06-19
179631336827974K130295LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM.NBW2013-06-21
179631984444744K112877COMEN MULTI-PARAMETER PATIENT MONITORMWI2012-11-07
179631205743650K082275CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL IGM-0023LCP2010-01-14

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NBW32018-09-19
KNG12014-01-24
DXN12013-06-19
MWI12012-11-07
LCP12010-01-14

GUDID#