510(k) K123844

CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST by Chemtron Biotech, Inc. — Product Code JHI

K123844 is an FDA 510(k) premarket notification submitted by Chemtron Biotech, Inc. for the device "CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST". The FDA issued a decision of Substantially Equivalent on May 30, 2013. The device falls under product code JHI (Visual, Pregnancy Hcg, Prescription Use), a Class II device regulated under 21 CFR 862.1155. Chemtron Biotech, Inc. has at least 10 other 510(k) clearances on record.