FDA 510(k) Applications for Medical Device Product Code "DKJ"
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FDA 510(k) Number | Applicant | Device Name | Decision Date |
K020794 | BAYER DIAGNOSTICS CORP. | SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | 07/11/2002 |
K014173 | BECKMAN COULTER, INC. | SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR | 02/15/2002 |
K964715 | DADE INTL., INC. | PARAMAX SALICYLATE REAGENT | 04/25/1997 |
K980032 | DIAGNOSTIC CHEMICALS LTD. | SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71 | 03/02/1998 |
K042329 | DIAGNOSTIC CHEMICALS LTD. | SALICYLATE-SL ASSAY | 12/27/2004 |
K981872 | DIAGNOSTIC CHEMICALS LTD. | SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40 | 06/29/1998 |
K961131 | DIAGNOSTIC REAGENTS, INC. | SALICYLATE ASSAY | 04/29/1996 |
K093939 | SIEMENS HEALTHCARE DIAGNOSTICS | ADVIA CHEMISTRY SALICYLATE REAGENT | 05/19/2010 |
K011878 | SYVA CO. | EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL | 08/13/2001 |