{"product_id":"fda-510k-k152768-assure-tech-hcg-pregnancy-serum-urine-combo-test-cassette-and-strip","title":"FDA 510(k) K152768, Assure Tech hCG Pregnancy Serum\/Urine Combo Test Cassette and Strip, by Assure Tech. Co., Ltd.","description":"\u003cp\u003e\u003cstrong\u003eDevice Classification Name\u003c\/strong\u003e    Visual, Pregnancy Hcg, Prescription Use\u003cbr\u003e\u003cstrong\u003e510(k) Number  \u003c\/strong\u003e  K152768\u003cbr\u003e\u003cstrong\u003eDevice Name\u003c\/strong\u003e    Assure Tech hCG Pregnancy Serum\/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum\/Urine Combo Test Strip\u003cbr\u003e\u003cstrong\u003eApplicant  \u003c\/strong\u003e  ASSURE TECH. CO., LTD.\u003cbr\u003e\u003cstrong\u003eRegulation Number \u003c\/strong\u003e   862.1155\u003cbr\u003e\u003cstrong\u003eClassification Product Code\u003c\/strong\u003e    JHI  \u003cbr\u003e\u003cstrong\u003eDate Received \u003c\/strong\u003e   09\/24\/2015\u003cbr\u003e\u003cstrong\u003eDecision Date \u003c\/strong\u003e   02\/24\/2016\u003cbr\u003e\u003cstrong\u003eDecision\u003c\/strong\u003e    Substantially Equivalent (SESE)\u003cbr\u003e\u003cstrong\u003eRegulation Medical Specialty \u003c\/strong\u003e   Clinical Chemistry\u003c\/p\u003e\n\u003cp\u003e\u003cmeta charset=\"utf-8\"\u003e\u003cstrong data-start=\"57\" data-end=\"73\"\u003eTotal pages:\u003c\/strong\u003e 349\u003cbr data-start=\"77\" data-end=\"80\"\u003e\u003cstrong data-start=\"80\" data-end=\"105\"\u003eFully redacted pages:\u003c\/strong\u003e 234\u003cbr data-start=\"109\" data-end=\"112\"\u003e\u003cstrong data-start=\"112\" data-end=\"130\"\u003eContent pages:\u003c\/strong\u003e 115\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51429457821860,"sku":"FDA510K152768","price":322.33,"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-k152768-assure-tech-hcg-pregnancy-serum-urine-combo-test-cassette-and-strip","provider":"FOIA Document Source","version":"1.0","type":"link"}