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FDA 510(k) Applications for Medical Device Product Code "DIH"
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FDA 510(k) Number | Applicant | Device Name | Decision Date |
K001344 | BAYER CORP. | ADVIA IMS | 06/26/2000 |
K013750 | BAYER DIAGNOSTICS CORP. | ADVIA 1650 CHOLINESTERASE ASSAY | 01/18/2002 |
K103373 | BECKMAN COULTER, INC. | SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722 | 02/07/2011 |
K002792 | CARESIDE, INC. | CARESIDE CHOLINESTERASE | 11/08/2000 |
K955498 | DIAGNOSTIC CHEMICALS LTD. | CHOLINESTERASE ASSAY KIT, CATALOGUE# 300-05 | 01/24/1996 |
K961656 | EQM RESEARCH, INC. | TEST-MATE CHE CHOLINESTERASE TEST SYSTEM | 11/26/1996 |
K943367 | INSTRUMENTATION LABORATORY CO. | IL TEST CHOLINESTERASE | 02/05/1996 |
K030045 | OLYMPUS AMERICA, INC. | OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114) | 02/21/2003 |
K061093 | ROCHE DIAGNOSTICS CORP. | CHOLINESTERASE GEN.2 TEST SYSTEM | 07/03/2006 |
K051444 | SENTINEL CH. SRL | SENTINEL CHOLINESTERASE LIQUID | 06/20/2005 |
K023992 | WIENER LABORATORIES S.A.I.C. | WIENER LAB COLINESTERASA AA | 02/12/2003 |