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FDA 510(k), K110212, INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP
FDA 510(k), K110212, INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP
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510(K) Number: K110212
Device Name: INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP
Manufacturer: ALERE SAN DIEGO, INC (FORMALLY BIOSITE INCORPORATE
Device Classification Name: test, time, prothrombin
Regulation Number: 864.7750
Classification Product Code: GJS
Date Received: 01/25/2011
Decision Date: 05/01/2012
Regulation Medical Specialty: Hematology
Device Name: INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP
Manufacturer: ALERE SAN DIEGO, INC (FORMALLY BIOSITE INCORPORATE
Device Classification Name: test, time, prothrombin
Regulation Number: 864.7750
Classification Product Code: GJS
Date Received: 01/25/2011
Decision Date: 05/01/2012
Regulation Medical Specialty: Hematology
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- 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.
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