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

Humanitarian Device Exemption (HDE)
  • 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
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device.
 
Trade NameTAS ECT TEST
Classification Nametest, ecarin clotting time (ect)
Generic Nametest, ecarin clotting time (ect)
Applicant
CARDIOVASCULAR DIAGNOSTICS, INC.
9401 globe center dr.
suite 140
morrisville, NC 27560
HDE NumberH990012
Supplement NumberS001
Date Received02/05/2004
Decision Date08/31/2004
Product Code
NDV
Advisory Committee Hematology
Supplement Typenormal 75 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Replacement of the knoll pharmaceuticals peg hirudin with refludan r-hirudin;an increase in lot release acceptance criteria, from precision of 8% to 10%cv, for clotting times of the ect test cards;removal of the in-process range of 180-190 seconds for target clotting times;replacement of the card calibration test procedure.
-
-