Thermo Fisher Scientific

FDA Filings

This page includes the latest FDA filings for Thermo Fisher Scientific. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

Manufacturer	Device Name	Date
K192729 Thermo Fisher Scientific	Sensititre 18-24 Hour MIC Or Breakpoint Susceptibility System With Lefamulin In The Dilution Range Of 0.008-16ug/ml	2019-11-06
K191914 Thermo Fisher Scientific	Thermo Scientific Sensititre ARIS HiQ System	2019-11-06
K191918 Thermo Fisher Scientific	Thermo Scientific Sensititre ARIS HiQ System	2019-11-06
K192250 Thermo Fisher Scientific	Sensititre 18-24 Hour MIC Or Breakpoint Susceptibility System With Imipenem-Relebactam In The Dilution Range Of 0.03/4-256/4 Ug/mL	2019-10-16
K183324 Thermo Fisher Scientific	Sensititre 20-24 Hour Haemophilus Influenzae/Streptococcus Pneumoniae MIC Or Breakpoint Susceptibility System With Omadacycline In The Dilution Range Of 0.008 - 32 Ug/mL	2019-02-15
K182797 Thermo Fisher Scientific	Sensititre 18-24 Hour MIC Or Breakpoint Susceptibility System With Eravacycline In The Dilution Range Of 0.008- 16 µg/mL	2018-11-30
K181946 Thermo Fisher Scientific	Sensititre 18-24 Hour MIC Breakpoint Susceptibility System With Plazomicin In The Dilution Range Of 0.06-128 Ug/mL	2018-08-08
K173209 Thermo Fisher Scientific	Sensititre 18-24 Hour MIC Or Breakpoint Susceptibility System With Meropenem/Vaborbactam In The Dilution Range Of 0.008/8 - 18/8 Ug/mL	2017-12-01
K110035 THERMO FISHER SCIENTIFIC OY	INDIKO	2011-06-28
K092819 Thermo Fisher Scientific	REMEL SPECTRA VRE	2010-07-15
K090429 THERMO FISHER SCIENTIFIC (NALGE NUNC INTL)	NUNC IVF CENTERWELL AND ICSI DISHES	2009-09-18
K091617 Thermo Fisher Scientific	QMS LIDOCAINE CALIBRATORS, MODEL 0374678	2009-07-17
K090282 THERMO FISHER SCIENTIFIC INC.	QMS LIDOCAINE	2009-05-29
K081083 Thermo Fisher Scientific	CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACID CONTROLS	2008-12-19
K080085 Thermo Fisher Scientific	MAS TOX CONTROL	2008-04-30
K070064 Thermo Fisher Scientific	AMYLASE EPS REAGENT	2007-05-22

Latest Premarket Applications

PMA	Manufacturer	Device Name	Date

Latest De Novo Filings

De Novo	Manufacturer	Device Name	Date

GUDID Registrations

Device GUDID Device Name	Manufacturer	Date
10815773020264 BT Sure	THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC	2019-07-08
10815773020257 BT Sure	THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC	2019-07-08
10815773020240 BT Sure	THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC	2019-07-08
37503025060164 Sterile Specimen Container	Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.	2018-12-10
37503025060133 Sterile Specimen Container	Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.	2018-12-10
37503025060348 Samco Clicktainer	Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.	2018-10-10
37503025060331 Samco Clicktainer	Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.	2018-10-10
37503025060324 Samco Clicktainer	Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.	2018-10-10
37503025060317 Samco Clicktainer	Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.	2018-10-10
57503025060304 Samco Clicktainer	Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.	2018-10-10
57503025060298 Samco Clicktainer	Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.	2018-10-10
57503025060281 Samco Clicktainer	Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.	2018-10-10
57503025060267 Samco Clicktainer	Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.	2018-10-10
57503025060250 Samco Clicktainer	Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.	2018-10-10
37503025060249 Samco Clicktainer	Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.	2018-10-10
37503025060225 Samco Clicktainer	Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.	2018-10-10
37503025060218 Samco Clicktainer	Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.	2018-10-10
57503025060205 Samco Clicktainer	Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.	2018-10-10
37503025060195 Sterile Specimen Container	Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.	2018-10-10
37503025060188 Sterile Specimen Container	Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.	2018-10-10
37503025060171 Sterile Specimen Container	Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.	2018-10-10
37503025060157 Sterile Specimen Container	Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.	2018-10-10
37503025060140 Sterile Specimen Container	Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.	2018-10-10
37503025060126 Sterile Specimen Container	Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.	2018-10-10
37503025060119 Sterile Specimen Container	Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.	2018-10-10
37503025060102 Sterile Specimen Container	Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.	2018-10-10
37503025060096 Sterile Specimen Container	Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.	2018-10-10
37503025060089 Sterile Specimen Container	Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.	2018-10-10
37503025060072 Sterile Specimen Container	Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.	2018-10-10
37503025060065 Sterile Specimen Container	Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.	2018-10-10
37503025060058 Sterile Specimen Container	Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.	2018-10-10
37503025060041 Sterile Specimen Container	Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.	2018-10-10
37503025060034 Sterile Specimen Container	Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.	2018-10-10
37503025060027 Sterile Specimen Container	Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.	2018-10-10
37503025060010 Sterile Specimen Container	Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.	2018-10-10