FDA 510(k), K093243, COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM
FDA 510(k), K093243, COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM
Regular price
$149.00 USD
Regular price
Sale price
$149.00 USD
Unit price
/
per
510(K) Number: K093243
Device Name: COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM
Manufacturer: COAGUSENSE, INC
Device Classification Name: Test, Time, Prothrombin
Regulation Number: 864.7750
Classification Product Code: GJS
Date Received: 10/15/2009
Decision Date: 04/07/2010
Regulation Medical Specialty: Hematology
Device Name: COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM
Manufacturer: COAGUSENSE, INC
Device Classification Name: Test, Time, Prothrombin
Regulation Number: 864.7750
Classification Product Code: GJS
Date Received: 10/15/2009
Decision Date: 04/07/2010
Regulation Medical Specialty: Hematology
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
View full details