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 Products, Red-Cell Lysing Products
510(k) Number K850944
Device Name NSI LYSING-D REAGENT -4000 ML
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 Number864.8540
Classification Product Code
GGK  
Date Received03/07/1985
Decision Date 03/29/1985
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
-
-