{"product_id":"fda-510k-k000471","title":"FDA 510(k) K000471, FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT, by Future Diagnostics B.V.","description":"\u003cp\u003e\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003eRadioimmunoassay, Parathyroid Hormone\u003cbr\u003e\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK000471\u003cbr\u003e\u003cstrong\u003eDevice Name:\u003c\/strong\u003e FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT\u003cbr\u003e\u003cstrong\u003eApplicant:\u003c\/strong\u003e Future Diagnostics B.V.\u003cbr\u003e\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e862.1545\u003cbr\u003e\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003eCEW\u003cbr\u003e\u003cstrong\u003eDate Received: \u003c\/strong\u003e02\/14\/2000\u003cbr\u003e\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 04\/11\/2000\u003cbr\u003e\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003cbr\u003e\u003cstrong\u003eRegulation Medical Specialty: \u003c\/strong\u003eClinical Chemistry\u003cbr\u003e\u003cstrong\u003e510k Review Panel: \u003c\/strong\u003eClinical Chemistry\u003cbr\u003e\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eTotal number of pages:\u003c\/strong\u003e 16\u003cbr\u003e\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 1\u003cbr\u003e\u003cstrong\u003eContent pages:\u003c\/strong\u003e 15\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51308062867620,"sku":"FDA510K000471","price":175.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k000471","provider":"FOIA Document Source","version":"1.0","type":"link"}