Athena Medical Corp.
United StatesFDA 510(k) applicant, unverified
- Devices
- 2
What Athena Medical Corp. makes
Athena Medical Corp. manufactures lateral flow immunoassay devices for detecting human chorionic gonadotropin (hCG) in urine samples. These include a home pregnancy test and a professional-grade version designed for clinical use, both intended for single-step, qualitative pregnancy confirmation.
The company’s products fall under FDA Class II regulatory classification and are listed via the 510(k) pathway. These devices are intended for use in the United States, where they are subject to compliance with FDA requirements for in vitro diagnostic (IVD) devices.
Catalogue
Affirm One-Step Home Pregnancy Test Ref K962888
510(k) 510(k)Affirm One-Step Professional Pregnancy Test Ref K964574
510(k) 510(k)
Frequently asked questions
How many devices does Athena Medical Corp. have in the registry?
The registry currently lists 2 devices for Athena Medical Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Athena Medical Corp.'s devices?
Among its 2 most recently registered devices, Athena Medical Corp. has devices listed in FDA 510(k) (2 devices).
What risk classes do Athena Medical Corp.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Athena Medical Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Athena Medical Corp. in the registry?
The most recently registered devices listed for Athena Medical Corp. include AFFIRM ONE-STEP HOME PREGNANCY TEST and AFFIRM ONE-STEP PROFESSIONAL PREGNANCY TEST.