Cleared Traditional

i-STAT Hematocrit test with i-STAT Alinity System

K163342 · Abbott Laboratories · Hematology
Aug 2017
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K163342 is an FDA 510(k) clearance for the i-STAT Hematocrit test with i-STAT Alinity System, a Device, Hematocrit Measuring (Class II — Special Controls, product code JPI), submitted by Abbott Laboratories (Princton, US). The FDA issued a Cleared decision on August 22, 2017, 266 days after receiving the submission on November 29, 2016. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6400.

Submission Details

510(k) Number K163342 FDA.gov
FDA Decision Cleared SESE
Date Received November 29, 2016
Decision Date August 22, 2017
Days to Decision 266 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JPI — Device, Hematocrit Measuring
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.6400

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