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
1042701125
Device Listing 1042701125
Listing Summary
#
Listing key
1042701125
Premarket submission
K172913
Device
cobas Factor II and Factor V Test
Applicant
Roche Molecular Systems, Inc.
Product code
NPR
Decision date
2018-01-12
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
199742
2243471
2243471
ROCHE MOLECULAR SYSTEMS, INC.
1
N
2026-01-01
1080 US Highway 202 South Branchburg NJ US 08876