510(k) Report

Devices descending from P820060

7 later devices reach Abbott Afp-Eia Diagnostic Kit for Cancer 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—
+1K983031Vitros Immunodiagnostic Products Afp AssayOrtho-Clinical Diagnostics, Inc.199811
+1K983263Immulite Afp, Model Lkapi, LKAP5, Immulite 2000 Afp, Model L2KAP2Diagnostic Products Corp.19980—
+1K981354Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211Beckman Instruments, Inc.199831
+2K213626Vitros AfpOrtho Clinical Diagnostics20220—
+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—