FDA.reportPublic FDA data

ABBOTT DIABETES CARE INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
29543233002803444ABBOTT DIABETES CARE INC.1Y2026-01-011360 SOUTH LOOP RD. ALAMEDA CA US 94502

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
20891297052832P160030Freestyle Libre Flash Glucose Monitoring SystemPZE2017-09-27
20891886736038P150021FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEMMDS2016-09-23
20891801739957K233655Lingo Glucose SystemSAF2024-05-29
20891906589163K233537FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring SystemQBJ2024-04-23
20891585168177K223435FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring SystemQBJ2023-04-13
20891258269567K222447FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring SystemQBJ2023-03-03
20891409769041K221613Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet LancetsQRL2022-10-03
20891101188539K221433Facet 28G Universal LancetQRK2022-07-15
20891559735811K221126Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancetsFMK2022-08-12
20891058793223K213996FreeStyle Libre 3 Continuous Glucose Monitoring SystemQLG2022-05-26
20891381733731K212132FreeStyle Libre 3 Continuous Glucose Monitoring SystemQLG2022-05-26
20891330071498K210943FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)QLG2021-11-22
20891645037081K202145Bigfoot Unity Diabetes Management SystemQLG2021-05-07
20892042437618K201761FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)QLG2021-07-30
20891820507570K193371FreeStyle Libre 2 Flash Glucose Monitoring SystemQLG2020-06-12
20891965397186K171941FreeStyle Precision Neo Blood Glucose Test StripsNBW2017-09-27
20891503982995K152442Freestyle Freedom Blood Glucose Monitoring SytemNBW2015-12-17
20891247953832K152328FreeStyle InsuLinx Blood Glucose Monotioring SystemLFR2015-09-17
20891752609291K150531FreeStyle Freedom Lite Blood Glucose Monitoring SystemNBW2015-06-05
20891314706277K150332FreeStyle Lite Blood Glucose Monitoring SystemNBW2015-06-05
20891420663915K142928FreeStyle Precision Neo Blood Glucose Monitoring SystemNBW2015-09-30
20891264108213K140371FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TEST STRIPS (50CT), TEST STRIPS (100CT)NBW2014-09-30
20891468173118K132511FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEMNBW2013-12-24
20891649192015K130094FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEMNBW2013-06-27
20891316890997K123089FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001NBW2013-04-05
20891891318144K120568FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMNBW2012-03-29
20891089075446K092638FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23NBW2010-06-15
20891530081385K092602FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring SystemNBW2010-05-14
20891402529178K083225FREESTYLE AVIATOR INSULIN DELIVERY AND BLOOD GLUCOSE MONITORING SYSTEMLZG2009-02-20
20891690894252K083223RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50, STRIPS (20 COUNT): 70973-01LFR2009-04-16
20891208505481K081975RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BGMS 71030-01 STRIPS: 7103-01 (20 COUNT)NBW2008-11-26
20891118773059K080960PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM WITH MODELS BGMS:70900-03, 70090-02, G3CH STRIPSNBW2008-09-05
20891337434529K070984THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPSLFR2007-11-01
20891935177710K062770COPILOT HEALTH MANAGEMENT SYSTEMNBW2006-12-14
20891640471414K060768PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPSJIN2006-04-21
20891428488761K051839FREE-STYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM, MODEL 11001NBW2006-03-09
20891676282991K051213PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPSNBW2005-05-27
20891145111233K040814MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEMNBW2004-04-15
20891646937794K023256PRECISION XTRA/MEDISENSE OPTIUM/PRECISION EASY/MEDISENSE OPTIUM EASY BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLONBW2003-04-23
20891882859375K022941MEDISENSE PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM FOR BLOOD GLUCOSE TESTINGLFR2002-10-28
20891736479033K021960PRECISION POINT OF CARE BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLOGYLFR2002-08-16
20891519331754K010553PRECISION XTRA BLOOD GLUCOSE TEST STRIP WITH TRUEMEASURE TECHNOLOGYNBW2001-06-18
20891052980109
20891314905812
20891437997196
20891563580263
20891607738642

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NBW222017-09-27
QLG62022-05-26
LFR52015-09-17
QBJ32024-04-23
SAF12024-05-29
QRL12022-10-03
FMK12022-08-12
QRK12022-07-15
PZE12017-09-27
MDS12016-09-23
LZG12009-02-20
JIN12006-04-21

PMA#

92 records. Showing 1-40. Next

PMN#