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
1511044439
Device Listing 1511044439
Listing Summary
#
Listing key
1511044439
Premarket submission
K241220
Device
Tina-quant Lipoprotein(a) Gen.2 Molarity
Applicant
Roche Diagnostics Operations
Product code
DFC
Decision date
2025-01-24
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