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
1617994133
Device Listing 1617994133
Listing Summary
#
Listing key
1617994133
Premarket submission
K983507
Device
VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE ASSAY
Applicant
Ortho-Clinical Diagnostics, Inc.
Product code
JJY
Decision date
1998-11-04
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
15344
1319681
1000136573
ORTHO-CLINICAL DIAGNOSTICS, INC.
1
Y
2020-04-25
100 Indigo Creek Dr Rochester NY US 14626
91290
3007111389
3007111389
Ortho-Clinical Diagnostics
1
N
2020-04-25
Felindre Meadows Pencoed Bridgend GB CF35 5PZ