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, Time, Prothrombin
510(k) Number K021923
Device Name INRATIO SELF-TEST
Applicant
HEMOSENSE, INC.
600 VALLEY WAY
MILPITAS,  CA  95035
Applicant Contact Judith Blunt
Correspondent
HEMOSENSE, INC.
600 VALLEY WAY
MILPITAS,  CA  95035
Correspondent Contact Judith Blunt
Regulation Number864.7750
Classification Product Code
GJS  
Date Received06/11/2002
Decision Date 10/24/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-