{"product_id":"fda-510k-k121214-access-accutni-3-reagent-and-calibrators-for-the-access-2-system","title":"FDA 510(k) K121214, Access AccuTnI+3 Reagent and Calibrators for the Access 2 System, by Beckman Coulter, Inc.","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K121214\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e \nBeckman Coulter, Inc.\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e Immunoassay Method, Troponin Subunit\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 862.1215\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e MMI\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 04\/23\/2012\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 06\/14\/2013\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Clinical Chemistry","brand":"FDA","offers":[{"title":"Default Title","offer_id":51429469257892,"sku":"FDA510K121214","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-k121214-access-accutni-3-reagent-and-calibrators-for-the-access-2-system","provider":"FOIA Document Source","version":"1.0","type":"link"}