{"product_id":"fda-510k-k200065-cobas-liat-nucleic-acid-tests-influenza-a-b-influenza-a-b-and-rsv-strep-a","title":"FDA 510(k) K200065, cobas Liat Nucleic Acid Tests (Influenza A\/B; Influenza A\/B \u0026 RSV; Strep A), by Roche Molecular Systems, Inc.","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K200065\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e cobas Influenza A\/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A\/B \u0026amp; RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Roche Molecular Systems, Inc.\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e Respiratory Virus Panel Nucleic Acid Assay System\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e OCC\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e KXA \u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 01\/13\/2020 \u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 02\/10\/2020\n\u003cbr\u003e\u003cb\u003eDecision:\u003c\/b\u003e Substantially Equivalent (SESE)\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Microbiology","brand":"FDA","offers":[{"title":"Default Title","offer_id":51429474533540,"sku":"FDA510K200065","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-k200065-cobas-liat-nucleic-acid-tests-influenza-a-b-influenza-a-b-and-rsv-strep-a","provider":"FOIA Document Source","version":"1.0","type":"link"}