Abbott Laboratories - FDA 510(k) Cleared Devices

Cleared Jun 20, 2025

Alinity i Rubella IgG

K243168 · LFX

Microbiology · 263d

Cleared Aug 30, 2024

Alinity i Toxo IgM

K233932 · LGD

Microbiology · 260d

Cleared Aug 10, 2023

HAVAb IgG II

K222850 · LOL

Microbiology · 323d

Cleared Oct 27, 2022

Architect CMV IgG

K220949 · LFZ

Microbiology · 209d

Cleared May 19, 2022

ARCHITECT Toxo IgG

K210596 · LGD

Microbiology · 444d

Cleared Jun 15, 2016

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

K153730 · LIP

Microbiology · 170d

Cleared Dec 21, 2012

ABBOTT PLEX-ID FLU ASSAY

K121003 · OCC

Microbiology · 263d

Cleared Jun 28, 2012

ARCHITECT HAVAB-G

K113704 · LOL

Microbiology · 195d

Cleared Apr 16, 2007

ABBOTT ARCHITECT HAVAB-M

K063329 · LOL

Microbiology · 164d

Cleared Nov 18, 1998

ABBOTT TESTPACK PLUS H. PYLORI

K982362 · LYR

Microbiology · 135d

Cleared Mar 03, 1998

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

K971522 · GTZ

Microbiology · 312d

Cleared Mar 24, 1997

ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION)

K954301 · LFZ

Microbiology · 579d