Beckman Coulter, Inc. - FDA 510(k) Cleared Devices

Cleared Mar 13, 2026

Access anti-HBc IgM

K254059 · SEI

Microbiology · 86d

Cleared Feb 19, 2026

Access anti-HBc Total

K253687 · SEI

Microbiology · 90d

Cleared Jan 27, 2026

Access anti-HAV IgM

K251995 · LOL

Microbiology · 214d

Cleared Nov 17, 2025

Access Rubella IgG

K250588 · LFX

Microbiology · 263d

Cleared Sep 09, 2025

Access anti-HAV

K243846 · LOL

Microbiology · 267d

Cleared Aug 20, 2025

MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64...

K243804 · LTT

Microbiology · 252d

Cleared Aug 15, 2025

MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32...

K250036 · LTT

Microbiology · 219d

Cleared Jul 18, 2025

MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64...

K250084 · LTT

Microbiology · 186d

Cleared Mar 28, 2025

Access Toxo IgG

K242022 · LGD

Microbiology · 260d

Cleared Oct 11, 2024

Access Toxo IgM II

K242095 · LGD

Microbiology · 86d

Cleared Sep 06, 2024

Access Syphilis

K241427 · LIP

Microbiology · 109d

Cleared Apr 26, 2023

Access PCT

K222996 · PTF

Microbiology · 210d