FDA 510(k) Applications for Medical Device Product Code "JKC"
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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 |