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
1710901118
Device Listing 1710901118
Listing Summary
#
Listing key
1710901118
Premarket submission
K243863
Device
Opulus™ Lymphoma Precision
Applicant
Roche Molecular Systems, Inc.
Product code
QIH
Decision date
2025-05-30
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
199771
3004141078
3004141078
ROCHE MOLECULAR SYSTEMS, INC.
1
N
2026-01-01
4300 HACIENDA DRIVE PLEASANTON CA US 94588
218569
3009731198
3009731198
Roche Diagnostics Santa Clara
1
N
2026-01-01
2881 Scott Blvd. Santa Clara CA US 95050