510(k) Report

Devices descending from K981354

3 later devices reach Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071597Dimension Vista (R) Afp Flex (R) Reagent Cartridge, Model K6454, Dimension Vista (R)…Dade Behring, Inc.20082—
+2K100321Dimension Vista Loci CA 125 Flex Reagent Cartridge,and Dimensions Vista Loci 6 Cal…Siemens Healthcare Diagnostics20110—
+2K090236Dimension Vista Afp Flex Reagent Cartridge, Model 6454Siemens Healthcare Diagnostics20090—