510(k) Report

Devices descending from K023285

7 later devices reach Diastat Anti Cyclic Citrullinated Peptide (Anti-CCP) Elisa through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121576Immulite 2000 Anti-CCP Igg AssaySiemens Healthcare Diagnostics, Inc.20130—
+1K110296Axis-Shield Anti-CCPAxis-Shield Diagnostics, Ltd.20110—
+1K093954Bioplex 2200 Anti-CCP Kit on the Bioplex 2200 Multi-Analyte Detection SystemBio-Rad Laboratories201012
+1K063347Axsym Anti-CCP Reagent, Standard Calibrator and Control Kits, Models 3L91-20, 3L91-01…Axis-Shield Diagnostics, Ltd.20070—
+1K061165Elia CCP, Model 14-5515-01; Elia CCP Control, Model 83-1009-01Sweden Diagnostics (Us), Inc.200611
+2K151799EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250…Phadia AB20160—
+2K112810Multi-Analyte Detection SystemsBio-Rad Laboratories201102