FDA.reportPublic FDA data

Device Listing 1719554644

Listing Summary#

Listing key
1719554644
Premarket submission
K214117
Device
Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer
Applicant
Abbott Diagnostics Technologies AS
Product code
LCP
Decision date
2023-09-27