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510(k) K110212

INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP by Alere San Diego, Inc (Formally Biosite Incorporate — Product Code GJS

K110212 is an FDA 510(k) premarket notification submitted by Alere San Diego, Inc (Formally Biosite Incorporate for the device "INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP". The FDA issued a decision of SESU on May 1, 2012. The device falls under product code GJS (Test, Time, Prothrombin), a Class II device regulated under 21 CFR 864.7750.

Clearance Details

Decision
SESU ()
Decision Date
May 1, 2012
Date Received
January 25, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Time, Prothrombin
Device Class
Class II
Regulation Number
864.7750
Review Panel
HE
Submission Type

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  • K220282 — i-STAT PTplus Cartridge with the i-STAT 1 System (July 14, 2023)
  • K231711 — microINR System (July 11, 2023)
  • K211485 — STA- NeoPTimal (December 23, 2022)
  • K212779 — Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing (October 5, 2022)
  • K213426 — HemosIL ReadiPlasTin (August 16, 2022)
  • K201185 — microINR System (December 18, 2020)

FDA data resources