510(k) K131931

CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST by Chemtron Biotech, Inc. — Product Code LCX

K131931 is an FDA 510(k) premarket notification submitted by Chemtron Biotech, Inc. for the device "CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST". The FDA issued a decision of Substantially Equivalent on July 26, 2013. The device falls under product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter), a Class II device regulated under 21 CFR 862.1155. Chemtron Biotech, Inc. has at least 10 other 510(k) clearances on record.