Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
Company-Registration
1637869237
Device Listing 1637869237
Listing Summary
#
Listing key
1637869237
Premarket submission
K080227
Device
ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM
Applicant
Roche Diagnostics Corp.
Product code
MRZ
Decision date
2008-05-15
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
18855
9610126
3002806559
ROCHE DIAGNOSTICS GMBH
1
N
2027-01-01
SANDHOFER STRASSE 116 MANNHEIM Baden-Wurttemberg DE D-68305
199521
3011393376
3011393376
ROCHE DIABETES CARE, INC.
1
Y
2027-01-01
9115 Hague Road Indianapolis IN US 46250
199424
3011806823
3011806823
Roche Diabetes Care GmbH
1
N
2027-01-01
Sandhofer Strasse 116 Mannheim Baden-Wurttemberg DE 68305