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 Diluent, Blood Cell
510(k) Number K844782
Device Name NSI ELT-D DILUTING FLUID 4000ML
Applicant
Nobel Scientific Industries, Inc.
1423 Leslie Ave.
Alexandria,  VA  22301
Applicant Contact DALE E THOMPSON
Correspondent
Nobel Scientific Industries, Inc.
1423 Leslie Ave.
Alexandria,  VA  22301
Correspondent Contact DALE E THOMPSON
Regulation Number864.8200
Classification Product Code
GIF  
Date Received12/10/1984
Decision Date 03/05/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-