Abbott Laboratories - FDA 510(k) Cleared Devices

Cleared Sep 29, 2023

TBI

K232669 · QAT

Immunology · 28d

Cleared Mar 02, 2023

Traumatic brain injury (TBI) test

K223602 · QAT

Immunology · 90d

Cleared Jan 08, 2021

i-STAT TBI Plasma cartridge with the i-STAT Alinity System

K201778 · QAT

Immunology · 192d

Cleared Jan 15, 2003

RHEUMATOID FACTOR (RF)

K024067 · DHR

Immunology · 36d

Cleared Nov 24, 1999

ABBOTT ARCHITECH GLYCATED HEMOGLOBIN MASTERCHECK

K992710 · JJY

Immunology · 105d

Cleared Jun 01, 1999

CRP

K991372 · DCN

Immunology · 42d

Cleared May 11, 1999

ABBOTT ARCHITECT CEA

K990774 · DHX

Immunology · 63d

Cleared Mar 08, 1999

RF

K990035 · DHR

Immunology · 61d

Cleared Jan 29, 1999

APOLIPOPROTEIN A1

K983289 · DER

Immunology · 133d

Cleared Jan 26, 1999

APOB

K983281 · DFC

Immunology · 130d

Cleared Dec 07, 1998

ABBOTT ARCHITECT FERRITIN

K983759 · DBF

Immunology · 42d

Cleared Nov 04, 1998

IGM

K983132 · DFT

Immunology · 57d