{"product_id":"fda-510k-k062368-wako-lba-dcp-test-system-with-dcp-control-and-calibrator-sets","title":"FDA 510(k) K062368, Wako LBA DCP Test System with DCP Control and Calibrator Sets, by Wako Chemicals USA, Inc.","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K062368\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e \nWako Chemicals USA, Inc.\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 866.6030\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e OAU\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 08\/14\/2006\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 01\/31\/2007\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Immunology","brand":"FDA","offers":[{"title":"Default Title","offer_id":51429465948324,"sku":"FDA510K062368","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400","url":"https:\/\/foiadocs.com\/products\/fda-510k-k062368-wako-lba-dcp-test-system-with-dcp-control-and-calibrator-sets","provider":"FOIA Document Source","version":"1.0","type":"link"}