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Company-Registration
1486313368
Device Listing 1486313368
Listing Summary
#
Listing key
1486313368
Premarket submission
K182922
Device
MTS Omadacycline 0.002-32 µg/mL
Applicant
Liofilchem s.r.l.
Product code
JWY
Decision date
2018-12-14
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