510(k) Report

Devices descending from K010050

7 later devices reach Advia Centaur and Acs: 180 Folate Immunoassay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172201Atellica IM Folate AssaySiemens Healthcare Diagnostics, Inc.201803
+1K091332Aia-Pack RBC FolateTosoh Bioscience, Inc.20090—
+1K071224Dimension Vista Vitamin B12 and Folate Flex Reagent Cartridges and Loci 4 CalibratorDade Behring, Inc.200741
+2K121994Dimension Vista Vitamin B12 (VB12) Flex Reagent Cartridge, Dimension Vista Loci 4…Siemens Healthcare Diagnostics, Inc.20121—
+2K093645Exl Anem Cal, Model RC640Siemens Healthcare Diagnostics20100—
+2K093631B12 Reagent Cartridge and Fol Flex Reagent Cartridge, Model RF642 and RF644Siemens Healthcare Diagnostics20100—
+3K133512Loci Vitamin B12 (VB12) Flex Reagent Cartridge, Loci Anemia Calibrator (Anem Cal)Siemens Healthcare Diagnostics20140—