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 Test, Time, Prothrombin
510(k) Number K864283
Device Name SIMPLASTIN EXCEL
Applicant
Organon Teknika Corp.
5516 Nicholson Ln.
Kensington,  TX  20895
Applicant Contact SHELDON MAZURSKY
Correspondent
Organon Teknika Corp.
5516 Nicholson Ln.
Kensington,  TX  20895
Correspondent Contact SHELDON MAZURSKY
Regulation Number864.7750
Classification Product Code
GJS  
Date Received10/30/1986
Decision Date 12/04/1986
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
Recalls CDRH Recalls
-
-