FDA.reportPublic FDA data

SD BIOSENSOR, INC.

Matched from indexed company URL: SD Biosensor, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30121332123012133212SD BIOSENSOR, INC.1N2026-01-01C-4th&5th, 16, Deogyeong-daero 1556beon-gil, Yeongtong-gu Suwon-si Gyeonggi KR 16690

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1950101641428765K160282SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home SystemNBW2017-10-17
1950101271192629K151265SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring SystemNBW2015-11-24
1950101278589979K140827SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control SetLCP2015-09-30
1950101540979831K132929SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD GLUCONAVII MENTOR NFC BLOOD GLUCOSE MONITORING SYSTEMNBW2015-08-05
1950101743256044K123517GLUCOMENTOR BLOOD GLUCOSE MONITORING SYSTEM, GLUCOMENTOR MULTI BLOOD GLUCOSE MONITORING SYSTEMNBW2014-01-17
1950101711500349K100398SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEMNBW2010-06-09
1950101124564610K082683SD CHECK GOLDNBW2009-12-08
1950101289075393
1950101380241628
1950101474310877
1950101910827881
1950101169967242

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NBW62017-10-17
LCP12015-09-30

PMN#

GUDID#