Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Device, Automated Cell-Locating
510(k) Number K200595
Device Name CellaVision DC-1, CellaVision DC-1 PPA
Applicant
Cellavision Ab
Mobilvagen 12
Lund,  SE 22362
Applicant Contact Magnus Johnsson
Correspondent
Axteria Biomed Consulting, Inc.
8040 Cobble Creek Circle
Potomac,  MD  20854
Correspondent Contact Jinjie Hu
Regulation Number864.5260
Classification Product Code
JOY  
Date Received03/06/2020
Decision Date 10/16/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-