Atlas Medical

Atlas Medical produces home pregnancy test kits in midstream format, such as the ATLAS HOME PREGNANCY TEST (Model 70172001), as well as multi-drug screening test cups and panels. These devices are designed for detecting pregnancy hormones and multiple substances in urine samples, respectively.

Atlas Medical is based in the United States. The company’s location is relevant for understanding regulatory oversight and compliance with FDA requirements.

Atlas Medical’s devices, including pregnancy tests and multi-drug screening tests, are classified as Class II medical devices under FDA regulations. This classification requires premarket notification (510(k)) submissions to demonstrate substantial equivalence to a legally marketed predicate device, ensuring safety and effectiveness.

Atlas Medical’s devices are listed via the FDA’s 510(k) pathway, meaning they undergo premarket notification submissions to demonstrate compliance with regulatory requirements. While not all devices are publicly indexed in a single registry, their classification and submission history are documented in the FDA’s 510(k) database.