Device Listing 1539538257

Listing Summary#

Listing key
1539538257
Premarket submission
K123018
Device
ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE
Applicant
Alfa Wassermann Diagnostic Technologies, Inc.
Product code
CFR
Decision date
2013-04-23