FDA 510(k)

OralTox 口腔液体药物测试

K号: K171403 · 2018-02-02

决定日期2018-02-02

产品代码DJC

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决定实质等同

器械摘要

OralTox Oral Fluid Drug Test is the device name listed in this FDA 510(k) record. The listed applicant is Premier Biotech, Inc.. It received FDA 510(k) clearance on 2018-02-02 under 510(k) number K171403. The device is classified under product code DJC. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the OralTox Oral Fluid Drug Test?

OralTox Oral Fluid Drug Test is a medical device that received FDA 510(k) clearance on 2018-02-02. The listed applicant is Premier Biotech, Inc.. The 510(k) number is K171403.

When did OralTox Oral Fluid Drug Test receive FDA 510(k) clearance?

OralTox Oral Fluid Drug Test received FDA 510(k) clearance on 2018-02-02, under 510(k) number K171403.

Who is the listed applicant for OralTox Oral Fluid Drug Test?

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

What is the FDA product code for OralTox Oral Fluid Drug Test?

The FDA product code for OralTox Oral Fluid Drug Test is DJC.

列明Premier Biotech, 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。

K181305OralTox 口腔液体药物测试

相关器械（代码：DJC）

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。

官方来源

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