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 Slide Stainer, Automated
510(k) Number K933996
Device Name PROFIBLOT
Applicant
Tecan U.S., Ltd.
P.O. Box 8101
Hillsborough,  NC  27278
Applicant Contact DANIEL B ROARK
Correspondent
Tecan U.S., Ltd.
P.O. Box 8101
Hillsborough,  NC  27278
Correspondent Contact DANIEL B ROARK
Regulation Number864.3800
Classification Product Code
KPA  
Date Received08/17/1993
Decision Date 01/28/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-