FDA 510(k)

Accelerate 现象系统，Accelerate PhenoTest BC 套件

K号: K192665 · 2020-09-15

决定日期2020-09-15

产品代码PRH

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决定实质等同

器械摘要

Accelerate Pheno System, Accelerate PhenoTest BC Kit is the device name listed in this FDA 510(k) record. The listed applicant is Accelerate Diagnostics, Inc.. It received FDA 510(k) clearance on 2020-09-15 under 510(k) number K192665. The device is classified under product code PRH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Accelerate Pheno System, Accelerate PhenoTest BC Kit?

Accelerate Pheno System, Accelerate PhenoTest BC Kit is a medical device that received FDA 510(k) clearance on 2020-09-15. The listed applicant is Accelerate Diagnostics, Inc.. The 510(k) number is K192665.

When did Accelerate Pheno System, Accelerate PhenoTest BC Kit receive FDA 510(k) clearance?

Accelerate Pheno System, Accelerate PhenoTest BC Kit received FDA 510(k) clearance on 2020-09-15, under 510(k) number K192665.

Who is the listed applicant for Accelerate Pheno System, Accelerate PhenoTest BC Kit?

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

What is the FDA product code for Accelerate Pheno System, Accelerate PhenoTest BC Kit?

The FDA product code for Accelerate Pheno System, Accelerate PhenoTest BC Kit is PRH.

列明Accelerate Diagnostics, Inc.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。

K240854Accelerate 弧形系统

官方来源

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器械摘要

常见问题

相关临床试验

列明Accelerate Diagnostics, Inc.为申报人的其他记录

官方来源