FDA.reportPublic FDA data

Device Listing 1962659774

Listing Summary#

Listing key
1962659774
Premarket submission
K131554
Device
RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT
Applicant
Randox Laboratories, Ltd.
Product code
JJE
Decision date
2014-01-09