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
1378119063
Device Listing 1378119063
Listing Summary
#
Listing key
1378119063
Premarket submission
K252393
Device
VITROS Immunodiagnostic Products hs Troponin I Reagent Pack
Applicant
Ortho-Clinical Diagnostics, Inc.
Product code
MMI
Decision date
2025-10-29
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
312290
1319681
1000136573
ORTHO-CLINICAL DIAGNOSTICS, INC.
1
N
2026-01-01
100 Indigo Creek Dr Rochester NY US 14626
312720
3007111389
3007111389
Ortho-Clinical Diagnostics
1
N
2026-01-01
Felindre Meadows Pencoed Bridgend GB CF35 5PZ