Cleared Traditional

i-STAT PTplus Cartridge with the i-STAT 1 System

K220282 · Abbott Laboratories · Hematology

Jul 2023

Decision

528d

Days

Class 2

Risk

About This 510(k) Submission

K220282 is an FDA 510(k) clearance for the i-STAT PTplus Cartridge with the i-STAT 1 System, a Test, Time, Prothrombin (Class II — Special Controls, product code GJS), submitted by Abbott Laboratories (Princton, US). The FDA issued a Cleared decision on July 14, 2023, 528 days after receiving the submission on February 1, 2022. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7750.

Submission Details

510(k) Number	K220282 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 01, 2022
Decision Date	July 14, 2023
Days to Decision	528 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF