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, Qualitative And Quantitative Factor Deficiency
510(k) Number K942087
Device Name BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATES
Applicant
Biopool AB
1016 Sutton Dr.
Unit C8, Burlington
Ontario, L7l 6b8,  CA L7L 6B8
Applicant Contact ANDREW L CERSKUS
Correspondent
Biopool AB
1016 Sutton Dr.
Unit C8, Burlington
Ontario, L7l 6b8,  CA L7L 6B8
Correspondent Contact ANDREW L CERSKUS
Regulation Number864.7290
Classification Product Code
GGP  
Date Received05/02/1994
Decision Date 07/13/1995
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
-
-