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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 / November 2025 / K251538

510(k) cleared

Status COVID-19/Flu A&B

Princeton BioMeditech Corp. · Nov 14, 2025 · K251538

FDA cleared the Status COVID-19/Flu A&B from Princeton BioMeditech Corp. on Nov 14, 2025 under K251538, a dual track 510(k). The device falls under product code SCA, Multi-Analyte Respiratory Virus Antigen Detection Test, regulated at 21 CFR 866.3987 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on May 19, 2025. The decision came 179 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Princeton BioMeditech Corp. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251538?

K251538 is the FDA 510(k) for Status COVID-19/Flu A&B, submitted by Princeton BioMeditech Corp.. FDA's decision date was Nov 14, 2025, under product code SCA (Multi-Analyte Respiratory Virus Antigen Detection Test).

Who makes the Status COVID-19/Flu A&B?

Princeton BioMeditech Corp., based in Monmouth Junction, NJ, is the applicant of record for K251538.

How long did the K251538 review take?

FDA received the submission on May 19, 2025 and issued its decision on Nov 14, 2025, 179 days later.

← All decisions in November 2025