510(k) K052694

ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES. by Ind Diagnostic, Inc. — Product Code JHI

K052694 is an FDA 510(k) premarket notification submitted by Ind Diagnostic, Inc. for the device "ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.". The FDA issued a decision of Substantially Equivalent on December 16, 2005. The device falls under product code JHI (Visual, Pregnancy Hcg, Prescription Use), a Class II device regulated under 21 CFR 862.1155. Ind Diagnostic, Inc. has at least 7 other 510(k) clearances on record.