FDA.reportPublic FDA data

Rodney Huang

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
97104923003500908Rodney Huang1N2026-01-011360 South Loop Road Alameda CA US 94502

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
21621297052832P160030Freestyle Libre Flash Glucose Monitoring SystemPZE2017-09-27
21621886736038P150021FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEMMDS2016-09-23
21621801739957K233655Lingo Glucose SystemSAF2024-05-29
21621906589163K233537FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring SystemQBJ2024-04-23
21621585168177K223435FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring SystemQBJ2023-04-13
21621258269567K222447FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring SystemQBJ2023-03-03
21621058793223K213996FreeStyle Libre 3 Continuous Glucose Monitoring SystemQLG2022-05-26
21621381733731K212132FreeStyle Libre 3 Continuous Glucose Monitoring SystemQLG2022-05-26
21621330071498K210943FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)QLG2021-11-22
21622042437618K201761FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)QLG2021-07-30
21621820507570K193371FreeStyle Libre 2 Flash Glucose Monitoring SystemQLG2020-06-12
21621965397186K171941FreeStyle Precision Neo Blood Glucose Test StripsNBW2017-09-27
21621420663915K142928FreeStyle Precision Neo Blood Glucose Monitoring SystemNBW2015-09-30
21621264108213K140371FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TEST STRIPS (50CT), TEST STRIPS (100CT)NBW2014-09-30
21621468173118K132511FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEMNBW2013-12-24
21621649192015K130094FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEMNBW2013-06-27
21621690894252K083223RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50, STRIPS (20 COUNT): 70973-01LFR2009-04-16
21621208505481K081975RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BGMS 71030-01 STRIPS: 7103-01 (20 COUNT)NBW2008-11-26
21621118773059K080960PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM WITH MODELS BGMS:70900-03, 70090-02, G3CH STRIPSNBW2008-09-05
21621337434529K070984THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPSLFR2007-11-01
21621640471414K060768PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPSJIN2006-04-21
21621676282991K051213PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPSNBW2005-05-27
21621145111233K040814MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEMNBW2004-04-15
21621646937794K023256PRECISION XTRA/MEDISENSE OPTIUM/PRECISION EASY/MEDISENSE OPTIUM EASY BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLONBW2003-04-23
21621882859375K022941MEDISENSE PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM FOR BLOOD GLUCOSE TESTINGLFR2002-10-28
21621736479033K021960PRECISION POINT OF CARE BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLOGYLFR2002-08-16
21621519331754K010553PRECISION XTRA BLOOD GLUCOSE TEST STRIP WITH TRUEMEASURE TECHNOLOGYNBW2001-06-18
21621314905812
21621437997196

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NBW122017-09-27
QLG52022-05-26
LFR42009-04-16
QBJ32024-04-23
SAF12024-05-29
PZE12017-09-27
MDS12016-09-23
JIN12006-04-21