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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 / June 2026 / K253069

510(k) cleared

Lipoprotein (a) Molarity Assay

Diazyme Laboratories, Inc. · Jun 16, 2026 · K253069

FDA cleared the Lipoprotein (a) Molarity Assay from Diazyme Laboratories, Inc. on Jun 16, 2026 under K253069, a traditional 510(k). The device falls under product code DFC, Lipoprotein, Low-Density, Antigen, Antiserum, Control, regulated at 21 CFR 866.5600 as a Class 2 device. The review panel was Immunology.

FDA logged the submission as received on Sep 23, 2025. The decision came 266 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Diazyme Laboratories, Inc. has 2 other decisions in the tracker over the last 12 months: K252336 (Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay), K253358 (Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay).

Questions & Answers

What did FDA clear under K253069?

K253069 is the FDA 510(k) for Lipoprotein (a) Molarity Assay, submitted by Diazyme Laboratories, Inc.. FDA's decision date was Jun 16, 2026, under product code DFC (Lipoprotein, Low-Density, Antigen, Antiserum, Control).

Who makes the Lipoprotein (a) Molarity Assay?

Diazyme Laboratories, Inc., based in Poway, CA, is the applicant of record for K253069.

How long did the K253069 review take?

FDA received the submission on Sep 23, 2025 and issued its decision on Jun 16, 2026, 266 days later.

← All decisions in June 2026

Sources