FDA.reportPublic FDA data

Roche Operations, Ltd.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
26277232627723Roche Operations, Ltd.1N2020-04-252875 Ponce By-Pass, PO Box 7085 Ponce PR US 00732

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1994191885803343K131029ACCU-CHEK AVIVA PLUS TEST STRIPNBW2013-08-09
1994191423295526K043474ACCU-CHEK AVIVA SYSTEMLFR2005-04-27
1994191823780266

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NBW12013-08-09
LFR12005-04-27