I-STAT PROTHROMBIN TIME TEST— 510(k) K020355

Clearance details

Applicant

I-Stat Corporation

Product code

Code GJS

Device class

Class 2

Regulation

21 CFR 864.7750

Advisory panel

Hematology

Date received

2002-02-04

Decision date

2002-05-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

East Windsor, NJ, US

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Death

4

Injury

229

Malfunction

4,852

Total

5,085

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2361-2015 — i-Stat PT/INR Cartridges List number 03P89-24 The cartridges are packaged in sealed pouches, one per pouch. There are 24 cartridges packed in a box. a prothrombin time test useful in monitoring patients receiving oral anticoagulation therapy such as coumadin or warfarin.Class II·Terminated·Abbott Point Of Care Inc.·20150615
• Z-0451-2014 — Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a prothrombin time test is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or Warfarin. The cartridge is to be used with the i-Stat 1 Analyzer and as part of the i-Stat System, the PT/INR test is to be used by trained health care professionals in accordance with a facility's policies and procedures.Class II·Terminated·Abbott Point Of Care Inc.·20131028
• Z-2157-2012 — I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or warfarin.Class II·Terminated·Abbott Point Of Care Inc.·20120301

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K020355.