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FDA 510(k)

FilmArray 呼吸检测板 EZ (RP EZ)

K号: K152579 · 2016-10-03

申请人Biofire Diagnostics, LLC
决定日期2016-10-03
产品代码OCC
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决定实质等同

器械摘要

FilmArray Respiratory Panel EZ (RP EZ) is the device name listed in this FDA 510(k) record. The listed applicant is Biofire Diagnostics, LLC. It received FDA 510(k) clearance on 2016-10-03 under 510(k) number K152579. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the FilmArray Respiratory Panel EZ (RP EZ)?

FilmArray Respiratory Panel EZ (RP EZ) is a medical device that received FDA 510(k) clearance on 2016-10-03. The listed applicant is Biofire Diagnostics, LLC. The 510(k) number is K152579.

When did FilmArray Respiratory Panel EZ (RP EZ) receive FDA 510(k) clearance?

FilmArray Respiratory Panel EZ (RP EZ) received FDA 510(k) clearance on 2016-10-03, under 510(k) number K152579.

Who is the listed applicant for FilmArray Respiratory Panel EZ (RP EZ)?

The FDA 510(k) record lists Biofire Diagnostics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FilmArray Respiratory Panel EZ (RP EZ)?

The FDA product code for FilmArray Respiratory Panel EZ (RP EZ) is OCC.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Biofire Diagnostics, LLC为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K243544BIOFIRE SPOTFIRE 呼吸道/喉咙痛检测板迷你版K243885BIOFIRE FILMARRAY 胃肠道（GI）检测板中K243759BIOFIRE血培养鉴定2（BCID2）面板（RFIT-ASY-0147（30包装）RFIT-ASY-0148（6包装））K242367BIOFIRE FILMARRAY胃肠道（GI）面板K241194BIOFIRE SPOTFIRE 呼吸道/喉咙痛（R/ST）检测板迷你版K232954BIOFIRE SPOTFIRE 呼吸道/喉咙痛（R/ST）检测板

查看所有 20 个设备 →

相关器械（代码：OCC）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K262747ID NOW 流感A & B 2；ID NOW RSV；ID NOW 链球菌A 2；ID NOW COVID-19 2.0Abbott Diagnostics Scarborough, Inc.K254139BioCode® 呼吸道病原体检测板 (RPP)Applied BioCode, Inc.K242613NxTAG®呼吸道病原体检测板Luminex Molecular Diagnostics, Inc.K232775ID NOW 流感A & B 2Abbott Diagnostics Scarborough, Inc.K231017Panther Fusion AdV/hMPV/RV AssayHologic, Inc.K213822cobas流感A/B & RSV核酸检测，适用于cobas Liat系统Roche Molecular Systems, Inc.

官方来源

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