FDA 510(k) Applications for Medical Device Product Code "JKC"
(Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate))

FDA 510(k) Number Applicant Device Name Decision Date
K040181 BECKMAN COULTER, INC. ACCESS DHEA-S REAGENT ASSAY 03/24/2004
K955114 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL AACTIVE DHEA EIA KIT 02/23/1996
K962895 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL DHEA-S-7 09/10/1996
K973897 KMI DIAGNOSTICS, INC. DHEA-S 11/13/1997
K003174 ROCHE DIAGNOSTICS CORP. ELECSYS DHEA-S 01/17/2001


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