510(k) K942647

COLLEGE OF AMER PATH (CAP) SURV VALID PROST SPEC ANTI by Scantibodies Laboratory, Inc. — Product Code JJY

K942647 is an FDA 510(k) premarket notification submitted by Scantibodies Laboratory, Inc. for the device "COLLEGE OF AMER PATH (CAP) SURV VALID PROST SPEC ANTI". The FDA issued a decision of Substantially Equivalent on July 12, 1995. The device falls under product code JJY (Multi-Analyte Controls, All Kinds (Assayed)), a Class I device regulated under 21 CFR 862.1660. Scantibodies Laboratory, Inc. has at least 10 other 510(k) clearances on record.