CellaVision AB is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
CellaVision AB - FDA 510(k) Cleared Devices
Recent clearances: CellaVision DC-1, CellaVision DC-1 PPA
7
Total
7
Cleared
0
Denied
CellaVision AB has 7 FDA 510(k) cleared medical devices. Based in Minneapolis,, US.
Historical record: 7 cleared submissions from 2001 to 2020. Primary specialty: Hematology.
Browse the FDA 510(k) cleared devices submitted by CellaVision AB Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Axteria Biomed Consulting, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - CellaVision AB
7 devices
Cleared
Oct 16, 2020
CellaVision DC-1, CellaVision DC-1 PPA
Hematology
224d
Cleared
Aug 01, 2017
Advanced RBC Application
Hematology
89d
Cleared
Sep 16, 2011
CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION
Hematology
357d
Cleared
Nov 20, 2009
CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127
Hematology
63d
Cleared
Dec 05, 2008
CELLAVISION DM96 WITH THE BODY FLUID APPLICATION
Hematology
277d
Cleared
Feb 10, 2004
CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER
Hematology
62d
Cleared
Mar 15, 2001
DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER
Hematology
146d