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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 / March 2026 / K254167

510(k) cleared

MDx-Chex for BCY

Streck, LLC · Mar 17, 2026 · K254167

FDA cleared the MDx-Chex for BCY from Streck, LLC on Mar 17, 2026 under K254167, a traditional 510(k). The device falls under product code PMN, Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays, regulated at 21 CFR 866.3920 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Dec 23, 2025. The decision came 84 days later, inside the 90 FDA-day goal for a 510(k).

Streck, LLC has 2 other decisions in the tracker over the last 12 months: K260041 (MDx-Chex for BCP), K254166 (MDx-Chex for BCN).

Questions & Answers

What did FDA clear under K254167?

K254167 is the FDA 510(k) for MDx-Chex for BCY, submitted by Streck, LLC. FDA's decision date was Mar 17, 2026, under product code PMN (Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays).

Who makes the MDx-Chex for BCY?

Streck, LLC, based in La Vista, NE, is the applicant of record for K254167.

How long did the K254167 review take?

FDA received the submission on Dec 23, 2025 and issued its decision on Mar 17, 2026, 84 days later.

← All decisions in March 2026

Sources