510(k) K990138

DSL ACTIVE AFP ELISA, MODEL DSL-10-8400 by Diagnostic Systems Laboratories, Inc. — Product Code LOJ

K990138 is an FDA 510(k) premarket notification submitted by Diagnostic Systems Laboratories, Inc. for the device "DSL ACTIVE AFP ELISA, MODEL DSL-10-8400". The FDA issued a decision of Substantially Equivalent on June 21, 1999. The device falls under product code LOJ (Kit, Test,Alpha-Fetoprotein For Testicular Cancer), a Class II device regulated under 21 CFR 866.6010. Diagnostic Systems Laboratories, Inc. has at least 10 other 510(k) clearances on record.