510(k) K921211

NOW PREGNANCY TEST KIT by Bio Clinic Co. — Product Code JHI

K921211 is an FDA 510(k) premarket notification submitted by Bio Clinic Co. for the device "NOW PREGNANCY TEST KIT". The FDA issued a decision of Substantially Equivalent on May 7, 1992. The device falls under product code JHI (Visual, Pregnancy Hcg, Prescription Use), a Class II device regulated under 21 CFR 862.1155. Bio Clinic Co. has at least 10 other 510(k) clearances on record.