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
1615028640
Device Listing 1615028640
Listing Summary
#
Listing key
1615028640
Premarket submission
K223093
Device
Aptiva APS IgG Reagent; Aptiva APS IgM Reagent
Applicant
Inova Diagnostics, Inc.
Product code
MID
Decision date
2024-12-17
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
298690
3012348571
3012348571
INSTRUMENTATION LABORATORY SPA
1
N
2026-01-01
Via Leonardo da Vinci, 36 Roncello Lombardy IT 20877