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
1540655533
Device Listing 1540655533
Listing Summary
#
Listing key
1540655533
Premarket submission
K163636
Device
ePlex Respiratory Pathogen Panel
Applicant
Genmark Diagnostics, Incorporated
Product code
OCC
Decision date
2017-06-09
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
124441
3008632402
3008632402
GENMARK DIAGNOSTICS, INC.
1
N
2026-01-01
GenMark Diagnostics, Inc. 5964 La Place Ct Carlsbad CA US 92008