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
1641420750
Device Listing 1641420750
Listing Summary
#
Listing key
1641420750
Premarket submission
K153687
Device
Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL
Applicant
Liofilchem s.r.l.
Product code
JWY
Decision date
2016-03-31
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
198465
3003059313
3003059313
Laboratory Specialists, Inc.
1
Y
2020-04-25
26214 Center Ridge Road Cleveland OH US 44145
196334
3012389632
3012389632
LIOFILCHEM S.R.L.
1
N
2026-01-01
Via Scozia, Zona Industriale Roseto degli Abruzzi Teramo IT 64026
212624
3013661582
3013661582
Liofilchem, Inc.
1
Y
2026-01-01
465 Waverley Oaks Rd. Suite 317 Waltham MA US 02452