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 Activated Partial Thromboplastin
510(k) Number K022021
Device Name VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT
Applicant
Vital Scientific N.V.
One Gateway Center
Suite 411
Newton,  MA  02458
Applicant Contact ISRAEL M STEIN
Correspondent
Vital Scientific N.V.
One Gateway Center
Suite 411
Newton,  MA  02458
Correspondent Contact ISRAEL M STEIN
Regulation Number864.7925
Classification Product Code
GFO  
Date Received06/20/2002
Decision Date 11/01/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-