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 K110212
Device Name INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP
Applicant
ALERE SAN DIEGO, INC (FORMALLY BIOSITE INCORPORATE
9975 Summers Ridge Road
San Diego,  CA  92121
Applicant Contact MARA CALER
Correspondent
ALERE SAN DIEGO, INC (FORMALLY BIOSITE INCORPORATE
9975 Summers Ridge Road
San Diego,  CA  92121
Correspondent Contact MARA CALER
Regulation Number864.7750
Classification Product Code
GJS  
Date Received01/25/2011
Decision Date 05/01/2012
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT00933738
NCT01037270
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-