David Schultenover

FDA Filings

This page includes the latest FDA filings for David Schultenover. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 9610942
• FEI Number: 3007262384
• Name: David Schultenover
• Owner & Operator: THERMO FISHER SCIENTIFIC INC.
• Contact Address: 168 Third Avenue --; Waltham MA 02451 US
• US Agent:
  • David Schultenover
  • Microgenics Corporation, part of Thermo Fisher Scientific
  • 510 9795169
  • dave.schultenover@thermofisher.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 46500 Kato Road ; Fremont, CA 94538 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
JCB David Schultenover [THERMO FISHER SCIENTIFIC INC.]	Washing Solution 4.5%, Product No. IK703, IK704, 984030, 980929	2020-04-01
PSL David Schultenover [THERMO FISHER SCIENTIFIC INC.]	Cascadion? SM 25-Hydroxy Vitamin D Internal Standard, Ref. 10026958	2020-02-28
PSL David Schultenover [THERMO FISHER SCIENTIFIC INC.]	Cascadion? SM 25- Hydroxy Vitamin D Control 3, Ref. 10026930	2020-02-28
PSL David Schultenover [THERMO FISHER SCIENTIFIC INC.]	Cascadion? SM 25- Hydroxy Vitamin D Control 2, Ref. 10026929	2020-02-28
PSL David Schultenover [THERMO FISHER SCIENTIFIC INC.]	Cascadion? SM 25- Hydroxy Vitamin D Control 1, Ref. 10026928	2020-02-28
PSL David Schultenover [THERMO FISHER SCIENTIFIC INC.]	Cascadion? SM 25- Hydroxy Vitamin D Calibrator Set, Ref. 10026927	2020-02-28
DOP David Schultenover [THERMO FISHER SCIENTIFIC INC.]	TSQ Quantis MD Series	2014-05-17
DOP David Schultenover [THERMO FISHER SCIENTIFIC INC.]	TSQ Altis MD Series	2014-05-17
DOP David Schultenover [THERMO FISHER SCIENTIFIC INC.]	Endura MD	2014-05-17
DOP David Schultenover [THERMO FISHER SCIENTIFIC INC.]	Cascadion? SM Mixing Tip, Ref. 990110	2014-05-17
DOP David Schultenover [THERMO FISHER SCIENTIFIC INC.]	Cascadion? SM Extraction Vessel, Ref. 990100	2014-05-17
DOP David Schultenover [THERMO FISHER SCIENTIFIC INC.]	Cascadion? SM Clinical Analyzer, Ref. 99990000	2014-05-17
DOP David Schultenover [THERMO FISHER SCIENTIFIC INC.]	Cascadion? SM Accessory Cabinet, Ref. 990700	2014-05-17
PMN K110035 | JJE David Schultenover [THERMO FISHER SCIENTIFIC INC.]	Optilite, product no. 98640002	2011-07-01
PMN K110035 | JJE David Schultenover [THERMO FISHER SCIENTIFIC INC.]	Indiko, product no. 98630000	2011-07-01
PMN K110035 | JJE David Schultenover [THERMO FISHER SCIENTIFIC INC.]	Indiko Plus, product no. 98640000	2011-07-01
PMN K110035 | CFR David Schultenover [THERMO FISHER SCIENTIFIC INC.]	Optilite, product no. 98640002	2011-07-01
PMN K110035 | CFR David Schultenover [THERMO FISHER SCIENTIFIC INC.]	Indiko, product no. 98630000	2011-07-01
PMN K110035 | CFR David Schultenover [THERMO FISHER SCIENTIFIC INC.]	Indiko Plus, product no. 98640000	2011-07-01
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	Z-TURN, RIGHT	2004-09-22
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	Z-TURN, LEFT	2004-09-22
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	U-TURN, Mek	2004-09-22
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	TCA CONTROLLER PC Including SW Win10	2004-09-22
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	TCA 800 INTERFACE FOR COBAS 8000	2004-09-22
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	T-TURN	2004-09-22
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	SYSMEX HST Interface	2004-09-22
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	STORAGE, product no. 952311	2004-09-22
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	STAGO STA-R INTERFACE	2004-09-22
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	RECAPPER 110 VAC 60 HZ	2004-09-22
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	Propleix Reagent Preparation Incubator RPI (120V & 220-240V)	2004-09-22
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	Procleix Reagent Preparation Incubator RPI 250 (120V & 220-240V)	2004-09-22
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	Parallel Bypass TOSOH G8	2004-09-22
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	PERPENDICULAR BYPASS, TCA for COLD STORAGE RACK LOADER, product no. 952292	2004-09-22
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	PERPENDICULAR BYPASS VITROS 5.1 FS	2004-09-22
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	PARALLEL BYPASS VITROS 5.1 FS	2004-09-22
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	PARALLEL BYPASS TOSOH	2004-09-22
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	PARALLEL BYPASS OLYMPUS AU680	2004-09-22
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	PARALLEL BYPASS LIAISON XL	2004-09-22
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	PARALLEL BYPASS FOR ACL Top	2004-09-22
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	PARALLEL BYPASS BECKMAN Unicel Dxl 800	2004-09-22
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	LOADER, product no. 952312	2004-09-22
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	LAS PC Win10 including SW	2004-09-22
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	L-TURN	2004-09-22
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	INTERNAL U-TURN	2004-09-22
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	INTERFACE ImmunoCap 1000	2004-09-22
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	INTERFACE ARCHITECT i2000SR	2004-09-22
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	INTERFACE ARCHITECT C8000	2004-09-22
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	EXIT	2004-09-22
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	ES Flex	2004-09-22
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	ENTRY	2004-09-22
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	DECAPPER FLEX	2004-09-22
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	CONVEYOR 900 MM	2004-09-22
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	CONVEYOR 600 MM	2004-09-22
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	CONVEYOR 2400 MM	2004-09-22
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	CONVEYOR 2100 MM	2004-09-22
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	CONVEYOR 1800 MM	2004-09-22
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	CONVEYOR 1500 MM	2004-09-22
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	CONVEYOR 1200 MM	2004-09-22
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	CENTRIFUGE MODULE	2004-09-22
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	BUFFER	2004-09-22
LXG David Schultenover [THERMO FISHER SCIENTIFIC INC.]	ALIQUOTER AND LABELLER	2004-09-22

Similar & Related FDA Registered Companies

• Microgenics Corporation, part of Thermo Fisher Scientific