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 Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
510(k) Number K861146
Device Name MODEL K110SX CENTRIFUGE
Applicant
Jouan S.A.
Rte. 8 Box 1202
P.O. Box 2716
Winchester,  VA  22601
Applicant Contact DON GILLETTE
Correspondent
Jouan S.A.
Rte. 8 Box 1202
P.O. Box 2716
Winchester,  VA  22601
Correspondent Contact DON GILLETTE
Regulation Number862.2050
Classification Product Code
JQC  
Date Received03/26/1986
Decision Date 05/05/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-