510(k) K001215

DBEST HCG 2 IU/ML TEST KIT by Ameritek, Inc. — Product Code JHI

K001215 is an FDA 510(k) premarket notification submitted by Ameritek, Inc. for the device "DBEST HCG 2 IU/ML TEST KIT". The FDA issued a decision of Substantially Equivalent on June 22, 2000. The device falls under product code JHI (Visual, Pregnancy Hcg, Prescription Use), a Class II device regulated under 21 CFR 862.1155. Ameritek, Inc. has at least 10 other 510(k) clearances on record.