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 Plasma, Coagulation Factor Deficient
510(k) Number K962675
Device Name STA - LIATEST VWF TEST KIT
Applicant
AMERICAN BIOPRODUCTS CO.
5 CENTURY DR.
PARSIPPANY,  NJ  07054
Applicant Contact ANDREW LOC B. LE
Correspondent
AMERICAN BIOPRODUCTS CO.
5 CENTURY DR.
PARSIPPANY,  NJ  07054
Correspondent Contact ANDREW LOC B. LE
Regulation Number864.7290
Classification Product Code
GJT  
Date Received07/09/1996
Decision Date 10/25/1996
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
Recalls CDRH Recalls
-
-