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 Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name centrifuge, blood-bank for in vitro diagnostic use
510(k) Number BK870017
Tradename Fenwal LS-300 Centrifuge
Device Name Centrifuge, Blood Bank for in vitro Diagnostic Use
Original Applicant
Fenwal Inc
three corporate drive
lake zurich,  IL  60047
Regulation Number864.9275
Classification Product Code
KSO  
Date Received08/04/1987
Decision Date 11/16/1987
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product Yes
-
-