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 Lymphocyte Separation Medium
510(k) Number K860354
Device Name SEPRACELL LYMPHOCYTE SEPARATION MEDIUM
Applicant
SEPRATECH CORPORATION C/O KELLER AND HECKMAN
1150 17TH STREET, N.W.
SUITE 1000
WASHINGTON,  DC  20036
Applicant Contact LA CRUZ
Correspondent
SEPRATECH CORPORATION C/O KELLER AND HECKMAN
1150 17TH STREET, N.W.
SUITE 1000
WASHINGTON,  DC  20036
Correspondent Contact LA CRUZ
Regulation Number864.8500
Classification Product Code
JCF  
Date Received01/30/1986
Decision Date 04/18/1986
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
-
-