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 Station, Pipetting And Diluting, For Clinical Use
510(k) Number K894126
Device Name ROBOTIC SAMPLE PROCESSOR
Applicant
Tecan U.S., Ltd.
164 Dimmocks Mill Rd.
P.O. Box 8101
Hillsborough,  NC  27278
Applicant Contact DAVID JURANAS
Correspondent
Tecan U.S., Ltd.
164 Dimmocks Mill Rd.
P.O. Box 8101
Hillsborough,  NC  27278
Correspondent Contact DAVID JURANAS
Regulation Number862.2750
Classification Product Code
JQW  
Date Received06/12/1989
Decision Date 08/15/1989
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
-
-