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 Cells, Animal And Human, Cultured
510(k) Number K851561
Device Name WI-38 GENCELLS
Applicant
Genus Diagnostics
225 Wildwood St.
Woburn,  MA  01801
Applicant Contact PETER J MIONE
Correspondent
Genus Diagnostics
225 Wildwood St.
Woburn,  MA  01801
Correspondent Contact PETER J MIONE
Regulation Number864.2280
Classification Product Code
KIR  
Date Received04/16/1985
Decision Date 05/10/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-