510(k) K810214

DAC-CEL DIAGNATAL by Burroughs Wellcome Co. — Product Code JHI

K810214 is an FDA 510(k) premarket notification submitted by Burroughs Wellcome Co. for the device "DAC-CEL DIAGNATAL". The FDA issued a decision of Substantially Equivalent on March 6, 1981. The device falls under product code JHI (Visual, Pregnancy Hcg, Prescription Use), a Class II device regulated under 21 CFR 862.1155. Burroughs Wellcome Co. has at least 10 other 510(k) clearances on record.