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
1997420994
Device Listing 1997420994
Listing Summary
#
Listing key
1997420994
Premarket submission
K180296
Device
Afinion HbA1c Dx
Applicant
Alere Technologies AS
Product code
PDJ
Decision date
2018-05-07
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
346962
9613069
3003045237
Danial Kirmani
1
N
2026-01-01
150 S. Saunders Road Landmark of Lake Forest Lake Forest IL US 60045