510(k) Report

Devices descending from K981985

5 later devices reach Access Cea Reagents on the Access Immunoassay Analyzer Model 33200, 33205… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223921Access CEABeckman Coulter, Inc.20230—
+1K031270Access Cea Reagents for Use on the Access Immunoassay SystemsBeckman Coulter, Inc.200321
+1K991707Modification to Access Cea Reagents for Use on the Access Immunoassay Analyzer, Models…Beckman19994—
+2K071603Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea)Dade Behring, Inc.20081—
+3K100321Dimension Vista Loci CA 125 Flex Reagent Cartridge,and Dimensions Vista Loci 6 Cal…Siemens Healthcare Diagnostics20110—