510(k) K132085

ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM by Co-Innovation Biotech Co., Ltd. — Product Code LCX

K132085 is an FDA 510(k) premarket notification submitted by Co-Innovation Biotech Co., Ltd. for the device "ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM". The FDA issued a decision of Substantially Equivalent on November 12, 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. Co-Innovation Biotech Co., Ltd. has at least 9 other 510(k) clearances on record.