FDA 510(k)

Greiner Vacuette 尿液计数和培养，甘露醇管

K号: K163436 · 2017-03-06

决定日期2017-03-06

产品代码JSM

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决定实质等同

器械摘要

Greiner Vacuette Urine Count and Culture, Mannitol tube is the device name listed in this FDA 510(k) record. The listed applicant is Greiner Bio-One Na, Inc.. It received FDA 510(k) clearance on 2017-03-06 under 510(k) number K163436. The device is classified under product code JSM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Greiner Vacuette Urine Count and Culture, Mannitol tube?

Greiner Vacuette Urine Count and Culture, Mannitol tube is a medical device that received FDA 510(k) clearance on 2017-03-06. The listed applicant is Greiner Bio-One Na, Inc.. The 510(k) number is K163436.

When did Greiner Vacuette Urine Count and Culture, Mannitol tube receive FDA 510(k) clearance?

Greiner Vacuette Urine Count and Culture, Mannitol tube received FDA 510(k) clearance on 2017-03-06, under 510(k) number K163436.

Who is the listed applicant for Greiner Vacuette Urine Count and Culture, Mannitol tube?

The FDA 510(k) record lists Greiner Bio-One Na, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Greiner Vacuette Urine Count and Culture, Mannitol tube?

The FDA product code for Greiner Vacuette Urine Count and Culture, Mannitol tube is JSM.

列明Greiner Bio-One Na, 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。

K182078MiniCollect K2E K2EDTA管 K180545VACUETTE SAFELINK 套管式连接器 K173757VACUETTE EVOPROTECT 安全血液采集/输液套装 K160532Greiner Holdex

官方来源

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