FDA 510(k)

DC-UIBC-CAL

K号: K163078 · 2016-12-08

决定日期2016-12-08

产品代码JIT

咨询委员会CH 请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

DC-UIBC-CAL is the device name listed in this FDA 510(k) record. The listed applicant is Sekisui Diagnostics P.E.I., Inc.. It received FDA 510(k) clearance on 2016-12-08 under 510(k) number K163078. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DC-UIBC-CAL?

DC-UIBC-CAL is a medical device that received FDA 510(k) clearance on 2016-12-08. The listed applicant is Sekisui Diagnostics P.E.I., Inc.. The 510(k) number is K163078.

When did DC-UIBC-CAL receive FDA 510(k) clearance?

DC-UIBC-CAL received FDA 510(k) clearance on 2016-12-08, under 510(k) number K163078.

Who is the listed applicant for DC-UIBC-CAL?

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

What is the FDA product code for DC-UIBC-CAL?

The FDA product code for DC-UIBC-CAL is JIT.

列明Sekisui Diagnostics P.E.I., 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。

K202644对乙酰氨基酚 K182702SEKURE 肌酸激酶测定 K180835SEKURE 对乙酰氨基酚 L3K 测定 K173206SEKURE HbA1c 测定

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

器械摘要

常见问题

列明Sekisui Diagnostics P.E.I., Inc.为申报人的其他记录

相关器械（代码：JIT）

官方来源