WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / September 2025 / K243846

510(k) cleared

Access anti-HAV

Beckman Coulter, Inc. · Sep 9, 2025 · K243846

FDA cleared the Access anti-HAV from Beckman Coulter, Inc. on Sep 9, 2025 under K243846, a traditional 510(k). The device falls under product code LOL, Hepatitis A Test (Antibody And Igm Antibody), regulated at 21 CFR 866.3310 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Dec 16, 2024. The decision came 267 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Beckman Coulter, Inc. has 6 other decisions in the tracker over the last 12 months: K252169 (Access BNP II), K254059 (Access anti-HBc IgM), K253687 (Access anti-HBc Total), K251995 (Access anti-HAV IgM).

Questions & Answers

What did FDA clear under K243846?

K243846 is the FDA 510(k) for Access anti-HAV, submitted by Beckman Coulter, Inc.. FDA's decision date was Sep 9, 2025, under product code LOL (Hepatitis A Test (Antibody And Igm Antibody)).

Who makes the Access anti-HAV?

Beckman Coulter, Inc., based in Chaska, MN, is the applicant of record for K243846.

How long did the K243846 review take?

FDA received the submission on Dec 16, 2024 and issued its decision on Sep 9, 2025, 267 days later.

← All decisions in September 2025

Sources