Laboratory Specialists, Inc.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3003059313	3003059313	Laboratory Specialists, Inc.	1	Y	2020-04-25	26214 Center Ridge Road Cleveland OH US 44145

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
198465	2060326501	K200308	MTS Lefamulin 0.016- 256 µg/mL	JWY	2020-04-06
198465	1491981431	K192345	MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL	JWY	2019-10-31
198465	1525239630	K191908	MTS Imipenem 0.016-256 µg/mL	JWY	2019-09-04
198465	1807323288	K191809	MTS Imipenem-relebactam 0.002/4-32/4 µg/mL	JWY	2019-08-23
198465	1125284381	K190914	MTS Doxycycline 0.016 - 256 µg/mL	JWY	2019-05-29
198465	1963302993	K190252	MTS Gentamicin 0.016 - 256 µg/mL	JWY	2019-03-22
198465	1500561138	K183527	MTS Ciprofloxacin 0.002 - 32 µg/mL	JWY	2019-03-19
198465	1076208283	K183140	MTS Tetracycline 0.016 - 256 ug/mL	JWY	2019-01-11
198465	2048107894	K183115	MTS Levofloxacin 0.002 - 32 µg/mL	JWY	2018-12-20
198465	1486313368	K182922	MTS Omadacycline 0.002-32 µg/mL	JWY	2018-12-14
198465	1607200106	K182557	MTS Eravacycline 0.002 - 32 µg/mL	JWY	2018-11-02
198465	1479365012	K181889	MTS Penicillin 0.002- 32 µg/mL	JWY	2018-09-13
198465	1516525624	K181708	MTS Plazomicin 0.016-256 µg/mL	JWY	2018-07-31
198465	1836442240	K180886	Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL	JWY	2018-05-18
198465	1942941773	K180339	Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 µg/mL	JWY	2018-04-04
198465	1859005205	K180330	Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL	JWY	2018-03-15
198465	1857985575	K173817	Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 µg/mL	JWY	2018-02-28
198465	1175429910	K173307	Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL	JWY	2017-12-19
198465	1549567676	K172542	Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 mg/mL.	JWY	2017-10-23
198465	1205347853	K172109	Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 µg/mL	JWY	2017-09-27
198465	1454380141	K171906	Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 µg/mL	JWY	2017-08-01
198465	1198162733	K170892	Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 µg/mL	JWY	2017-05-25
198465	1293944412	K170772	Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 µg/mL	JWY	2017-06-07
198465	1852845626	K163517	Liofilchem MIC Test Strip (MTS) Telavancin 0.016 - 256.0 µg/mL	JWY	2017-03-14
198465	1465717422	K163298	Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 µg/mL	JWY	2017-02-22
198465	1049340622	K162854	Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml	JWY	2016-12-19
198465	1056732746	K161175	Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 mcg/mL	JWY	2016-07-12
198465	1641420750	K153687	Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL	JWY	2016-03-31
198465	1470644990	K153569	Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml	JWY	2016-06-22

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
JWY	29	2020-04-06