Device Listing 1187991251

Listing Summary#

Listing key
1187991251
Premarket submission
K070734
Device
MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON
Applicant
Diazyme Laboratories
Product code
LCP
Decision date
2007-04-09