Medical Device Manufacturer · US , Abbott Park , IL

Abbott Laboratories - FDA 510(k) Cleared Devices

883 submissions · 868 cleared · Since 1976

Recent clearances: Anti-HCV Next, ARCHITECT iGentamicin, Alinity i Rubella IgG

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883

Total

868

Cleared

0

Denied

FDA 510(k) Regulatory Record - Abbott Laboratories Microbiology ✕

85 devices

1-12 of 85

Cleared Apr 28, 2026

Microbiology · 270d

Cleared Jun 20, 2025

Alinity i Rubella IgG

Microbiology · 263d

Cleared Aug 30, 2024

Alinity i Toxo IgM

Microbiology · 260d

Cleared Aug 10, 2023

Microbiology · 323d

Cleared Oct 27, 2022

Architect CMV IgG

Microbiology · 209d

Cleared May 19, 2022

ARCHITECT Toxo IgG

Microbiology · 444d

Cleared Jun 15, 2016

ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT...

Microbiology · 170d

Cleared Dec 21, 2012

ABBOTT PLEX-ID FLU ASSAY

Microbiology · 263d

Cleared Jun 28, 2012

ARCHITECT HAVAB-G

Microbiology · 195d

Cleared Apr 16, 2007

ABBOTT ARCHITECT HAVAB-M

Microbiology · 164d

Cleared Nov 18, 1998

ABBOTT TESTPACK PLUS H. PYLORI

Microbiology · 135d

Cleared Mar 03, 1998

ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II

Microbiology · 312d

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