INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP


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

Correspodent Contact mara caler
Regulation Number 864.7750
Classification Product Code
GJS  
Date Received 01/25/2011
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 NCT00933738NCT01037270
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls