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
1000139075
Device Listing 1000139075
Listing Summary
#
Listing key
1000139075
Premarket submission
K241453
Device
Elecsys sFlt-1 and Elecsys PlGF
Applicant
Roche Diagnostics
Product code
QWH
Decision date
2025-02-07
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
18855
9610126
3002806559
Brian Frazier
1
N
2026-01-01
9115 Hague Rd Indianapolis IN US 46256