FDA.reportPublic FDA data

Leanne Kiviharju

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96130693003045237Leanne Kiviharju1N2020-04-259975 Summers Ridge Road San Diego CA US 92121

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1646011956337964K182988Afinion HbA1c Dx on Afinion 2PDJ2018-11-29
1646011261552122K171650Alere Afinion HbA1c and ACR on Afinion 2 analyzerLCP2017-11-21
1646011078538992K132031AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROLCHH2014-03-21
1646011398838987K110056AFINION ANALYZERLCP2011-02-15

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LCP22017-11-21
PDJ12018-11-29
CHH12014-03-21