510(k) K262299

Instant-View® hCG Combo II Cassette Test by Alfa Scientific Designs, Inc. — Product Code JHI

K262299 is an FDA 510(k) premarket notification submitted by Alfa Scientific Designs, Inc. for the device "Instant-View® hCG Combo II Cassette Test". The FDA issued a decision of Substantially Equivalent on Sep 22, 2026. The device falls under product code JHI (Visual, Pregnancy Hcg, Prescription Use), a Class II device regulated under 21 CFR 862.1155. Alfa Scientific Designs, Inc. has 43 other 510(k) clearances on record.