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 K092987
Device Name INRATIO/INRATIO2 TEST STRIPS
Applicant
BIOSITE INCORPORATED
9975 SUMMERS RIDGE RD
SAN DIEGO,  CA  92121
Applicant Contact KARIN A HUGES
Correspondent
BIOSITE INCORPORATED
9975 SUMMERS RIDGE RD
SAN DIEGO,  CA  92121
Correspondent Contact KARIN A HUGES
Regulation Number864.7750
Classification Product Code
GJS  
Date Received09/28/2009
Decision Date 06/11/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-