Thermogenesis Corp

FDA Filings

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

FDA Registration(s)
Registration Number2950374
FEI Number1000123765
NameThermoGenesis Corp.
Owner & OperatorThermoGenesis Corp.
Contact Address2711 CITRUS RD. --
Rancho Cordova CA 95742 US
Official Correspondent
  • Veronica - Runyan
  • x-916-8585120-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2711 Citrus Rd
RANCHO CORDOVA, CA 95742 US
Establishment Type
  • Complaint File Establishment per 21 CFR 820.198
  • Repack or Relabel Medical Device



FDA Filings

Device
Company
DeviceDate
Thermogenesis Corp.
ThermoGenesis AutoXpress 800552023-09-22
Thermogenesis Corp.
ThermoGenesis AXP 800562023-09-22
Thermogenesis Corp.
AXP Freezing Bag Set 801352023-09-21
Thermogenesis Corp.
PXP 2021-10-15
Thermogenesis Corp.
X-Counterweight 2021-10-12
Thermogenesis Corp.
X-WASH 2021-10-12
Thermogenesis Corp.
X-LAB 2021-10-12
Thermogenesis Corp.
X-WASH 2021-10-12
Thermogenesis Corp.
X-Counterweight 2021-10-12
Thermogenesis Corp.
X-Counterweight 2021-10-12
Thermogenesis Corp.
X-Counterweight 2021-10-12
Thermogenesis Corp.
X-Balance Ring Kit 2021-10-12
Thermogenesis Corp.
X-LAB 2021-10-12
Thermogenesis Corp.
Thermogenesis Start Up Accessory Kit, MarrowXpress 2021-10-12
Thermogenesis Corp.
PXP 2021-10-12
Thermogenesis Corp.
3D Bag Set 2021-10-12
Thermogenesis Corp.
PXP 2021-10-11
Thermogenesis Corp.
X-LAB 2021-10-11
Thermogenesis Corp.
DataTrak 2021-10-11
Thermogenesis Corp.
X- WASH 2021-10-11
Thermogenesis Corp.
X-WASH 2021-10-11
Thermogenesis Corp.
X-LAB 2021-10-11
Thermogenesis Corp.
X-WASH 2021-10-11
Thermogenesis Corp.
Thermogenesis BioArchive 2021-10-11
Thermogenesis Corp.
PXP-LAVARE 2021-10-11
Thermogenesis Corp.
PXP-LAVARE 2021-10-11
Thermogenesis Corp.
PXP-LAVARE 2021-10-11
Thermogenesis Corp.
PXP-LAVARE 2021-10-11
Thermogenesis Corp.
PXP-1000 2021-10-11
Thermogenesis Corp.
X-Wash Accessory Kit 2021-10-11
Thermogenesis Corp.
X- Mixer 2021-10-11
Thermogenesis Corp.
X-LAB 2021-10-07
Thermogenesis Corp.
PXP 2021-10-07
Thermogenesis Corp.
PXP 2021-10-07
Thermogenesis Corp.
Thermogenesis Start Up Accessory Kit, AXP 2021-10-07
Thermogenesis Corp.
PXP-LAVARE 2021-10-07
Thermogenesis Corp.
PXP-1000 2021-10-07
Thermogenesis Corp.
PXP-1000 2021-10-07
Thermogenesis Corp.
PXP-1000 2021-10-07
Thermogenesis Corp.
PXP-1000 Docking Station 2021-10-07
Thermogenesis Corp.
AXP Sorval 11754 Bucket Pads 8-51552021-01-21
ThermoGenesis Corp.
ThermoGenesis SARS-CoV-2(COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold)2020-04-15
ThermoGenesis Corp.
AXP II System2019-11-08
ThermoGenesis Corp
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices 2018-11-14
ThermoGenesis Corp.
SynGenX-1000 Platform2017-07-26
ThermoGenesis Corp.
PXP-1000 System2017-07-26
ThermoGenesis Corp.
X-WASH System2017-07-26
ThermoGenesis Corp.
X-LAB System2017-07-26
ThermoGenesis Corp.
CryoPRO Workstation2017-07-26
ThermoGenesis Corp.
Clotalyst2015-03-11
ThermoGenesis Corp.
PXP System2014-06-24
ThermoGenesis Corp.
MXP2014-06-24
ThermoGenesis Corp.
AXP Platform MarrowXpress System2014-06-24
ThermoGenesis Corp.
Res-Q60 PRP2011-12-01
ThermoGenesis Corp.
Cell Wash/Infusion Bag Set2010-05-11
ThermoGenesis Corp.
Freezing Bag2010-05-11
ThermoGenesis Corp.
Transfer/Freezing Bag Set2010-05-11
ThermoGenesis Corp.
Res-Q60 BMC2008-07-11
ThermoGenesis Corp.
AXP Platform MarrowXpress System2008-07-11
THERMOGENESIS CORP.
AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY)2008-07-10
ThermoGenesis Corp.
BioArchive2007-12-17
ThermoGenesis Corp.
AXP System2007-12-10
ThermoGenesis Corp.
AXP II System2007-12-10
ThermoGenesis Corp.
AXP AutoXpress Platform2007-12-10
THERMOGENESIS CORP.
CRYOSEAL FS APPLICATOR SYSTEM2007-08-16
THERMOGENESIS CORP.
THERMOGENESIS DROP APPLICATOR, KITS, SPRAY KITS AND TIPS1996-05-06

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020090552631Islas de Coco,Costa Rica -> Oakland, CaliforniaTUBING AND BAG SET KIT FOR STEM CEL320 CTN
2020090480286Islas de Coco,Costa Rica -> Oakland, CaliforniaTUBING AND BAG SET KIT FOR STEM CEL320 CTN
2020082165473Islas de Coco,Costa Rica -> Oakland, CaliforniaTUBING AND BAGSET KIT FOR STEM CELL320 CTN
2020072277315Caldera,Costa Rica -> Oakland, CaliforniaTUBING BAG SET KIT FOR STEM CELLS F320 CTN
2020071865976Caldera,Costa Rica -> Oakland, CaliforniaTUBING BAG SET KIT FOR STEM CELLS F20 PAL

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