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
1588146567
Device Listing 1588146567
Listing Summary
#
Listing key
1588146567
Premarket submission
K112120
Device
DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET
Applicant
Diazyme Laboratories
Product code
GHH
Decision date
2013-01-24
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
21855
2032900
3004445302
Diazyme Laboratories, Inc.
1
N
2026-01-01
12889 GREGG CT POWAY CA US 92064