Cellavision Ab

FDA Filings

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

SWEDENSTOCKHOLM STOCK EXCHANGECEVIDUNS 508663101
FDA Registration(s)
Registration Number3003630693
FEI Number3003630693
NameCELLAVISION AB
Owner & OperatorCELLAVISION AB
Contact AddressMobilvagen 12 --
LUND SE-NOTA SE-22362 SE
Official Correspondent
  • Magnus - Johnsson
  • 46-46-4601648-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressMobilvagen 12
LUND Skane lan [SE-12], SE-22362 SE
Establishment TypeComplaint File Establishment per 21 CFR 820.198



Registration Number3003463647
FEI Number3003463647
NameCELLAVISION, INC.
Owner & OperatorCELLAVISION AB
Contact AddressMobilvagen 12 --
LUND SE-NOTA SE-22362 SE
Official Correspondent
  • Magnus - Johnsson
  • 46-46-4601648-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address2530 Meridian Pkwy Ste 300
Durham, NC 27713 US



FDA Filings

Device
Company
DeviceDate
Cellavision AB
CellaVision DC-1 PPA 2020-10-30
Cellavision AB
CellaVision DC-1 2020-10-30
CellaVision AB
CellaVision DC-1, CellaVision DC-1 PPA2020-10-16
Cellavision AB
CellaVision® Server Softwaren, Upgrade to next generation CSS-0000NG2019-04-12
Cellavision AB
CellaVision® Server Softwaren Non-expiring license CSS-0000992019-04-12
Cellavision AB
DI Remote Review Software version 6.x.x AG5163352019-04-12
Cellavision AB
CellaVision® Remote Review Software, Enterprise Edition, version independent CRRS-GR00992019-04-12
Cellavision AB
CellaVision® Remote Review Software, Group Edition, version independent CRRS-GR00992019-04-12
Cellavision AB
CellaVision® Remote Review Software, Team Edition, version independent CRRS-TE00992019-04-12
Cellavision AB
CellaVision® Remote Review Software, Professional Edition, version independent CRRS-PR00992019-04-12
Cellavision AB
For DI Advanced RBC Application AB8592112019-04-12
Cellavision AB
For DI Remote Review Software version 5.0.x BC1885622019-04-12
Cellavision AB
For DI Body Fluid Application AG2417222019-04-12
Cellavision AB
For DI Remote Review Software version 6.x.x AD7425662019-04-12
Cellavision AB
CellaVision® Remote Review Software, Team Edition, version 6.0.x CRRS-TE60992019-04-12
Cellavision AB
CellaVision® Remote Review Software, Group upgrade from Team Ed. CRRS-GRTE992019-04-12
Cellavision AB
CellaVision® Remote Review Software, Group Edition version 6.0.x CRRS-GR60992019-04-12
Cellavision AB
CellaVision® Remote Review Software, Enterprise upgrade from Team Ed. CRRS-ENTE992019-04-12
Cellavision AB
CellaVision® Remote Review Software, Enterprise upgrade from Group Ed. CRRS-GRGR992019-04-12
Cellavision AB
CellaVision® Remote Review Software, Enterprise Edition, version 6.0.x CRRS-EN60992019-04-12
Cellavision AB
CellaVision® Remote Review Software version. 6.0.x, Non-expiring license CRRS-0060992019-04-12
Cellavision AB
CellaVision® Remote Review Software version 6.0.x, Annual license CRRS-0060012019-04-12
Cellavision AB
CellaVision® DM9600 XU-10288-012019-04-12
Cellavision AB
CellaVision® Body Fluid Application DM9600 CBF-9700992019-04-12
Cellavision AB
CellaVision® Advanced RBC Application DM9600 CAR-9700992019-04-12
Cellavision AB
CellaVision® Advanced RBC Application DM96 CAR-9600992019-04-12
Cellavision AB
CellaVision® Advanced RBC Application DM1200 CAR-1200992019-04-12
Cellavision AB
CellaVision® Remote Review Software version 5.0.x, Non-expiring license CRRS-0050992019-04-12
Cellavision AB
CellaVision® Remote Review Software version 5.0.x, Annual license CRRS-0050012019-04-12
Cellavision AB
CellaVision® Body Fluid Application DM96 CBF-9600992019-04-12
Cellavision AB
CellaVision® Body Fluid Application DM1200 CBF-1200992019-04-12
Cellavision AB
HemaPrep 2019-04-12
Cellavision AB
Automated Digital Morphology Analyzer DI-60 CC2862972019-04-12
Cellavision AB
CellaVision® DM1200 XU-10127-012019-04-12
Cellavision AB
CellaVision® DM96 XU-10020-012019-04-12
CELLAVISION AB
HemaPrep2018-08-30
CELLAVISION AB
DI-60 with Advanced RBC Application2017-10-27
CELLAVISION AB
CellaVision DM9600 with Advanced RBC Application2017-10-27
CELLAVISION AB
CellaVision DM96 and DM1200 with Advanced RBC Application2017-10-27
CELLAVISION AB
CellaVision Server Software2017-06-19
CELLAVISION AB
CellaVision Body Fluid Application2011-11-03
CELLAVISION AB
CellaVision Body Fluid Application for DM1200, DM9600 and DI-602011-11-03
CELLAVISION AB
CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION2011-09-16
CELLAVISION AB
CellaVision DM96002010-07-07
CELLAVISION AB
CellaVision DM12002010-07-07
CELLAVISION AB
Automated Digital Cell Morphology Analyzer DI-602010-07-07
CELLAVISION AB
CellaVision DM96002010-07-07
CELLAVISION AB
CellaVision DM12002010-07-07
CELLAVISION AB
Automated Digital Cell Morphology Analyzer DI-602010-07-07
CELLAVISION AB
Cellavision Body Fluid Application Non-Expiring license, DM962010-07-07
CELLAVISION AB
Cellavision Body Fluid Application Non-Expiring license, DM962010-07-07
CELLAVISION AB
CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-101272009-11-20
CELLAVISION AB
CELLAVISION DM96 WITH THE BODY FLUID APPLICATION2008-12-05
CELLAVISION AB
CellaVision DM962007-11-22
CELLAVISION AB
CellaVision DM962007-11-22
CELLAVISION AB
CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER2004-02-10
CELLAVISION AB
DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER2001-03-15

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