FDA.reportPublic FDA data

ROCHE DIABETES CARE, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30113933763011393376ROCHE DIABETES CARE, INC.1Y2027-01-019115 Hague Road Indianapolis IN US 46250

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1995211641018977P160017MiniMed 670G SystemOZP2016-09-28
1995211873962904K203711IWL2020 Blood Glucose Monitoring SystemNBW2022-05-06
1995211881244488K181131Accu-Chek Guide Me Blood Glucose Monitoring SystemNBW2018-12-13
1995211692597719K160944ACCU-CHEK Guide Blood Glucose Monitoring SystemNBW2016-08-31
1995211038903404K150910ACCU-CHEK Connect Diabetes Management AppNDC2015-06-03
1995211301228322K142089ACCU-CHEK AVIVA EXPERT SYSTEMLFR2014-12-17
1995211357083398K141929ACCU-CHEK CONNECT DIABETES MANAGEMENT APPNDC2015-03-16
1995211085570523K141867ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEMNBW2015-03-03
1995211816833212K133862ACCU-CHEK AVIVA PLUS SYSTEMNBW2014-04-29
1995211796756956K133741ACCU-CHEK Performa Blood Glucose Monitoring SystemNBW2014-08-29
1995211885803343K131029ACCU-CHEK AVIVA PLUS TEST STRIPNBW2013-08-09
1995211254619918K121679ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEMNBW2012-10-11
1995211424437190K113614ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEMNBW2013-02-12
1995211460102109K113137GLUCOSE TEST SYSTEMNBW2012-01-06
1995211770867973K111353ACCU-CHECK COMBO SYSTEMLZG2012-07-17
1995211716522509K101299ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEMLFR2011-09-21
1995211650120447K081389ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEMNBW2008-07-15
1995211637869237K080227ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEMMRZ2008-05-15
1995211559872066K062395ACCU-CHEK SMART PIXNBW2007-05-09
1995211423295526K043474ACCU-CHEK AVIVA SYSTEMLFR2005-04-27
1995211541170858
1995211823780266
1995211899490602
1995211974889799
1995211000542536
1995211227761079
1995211557491714
1995211638613398
1995211866399870
1995212018107398

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NBW122022-05-06
LFR32014-12-17
NDC22015-06-03
OZP12016-09-28
LZG12012-07-17
MRZ12008-05-15

PMN#