URITEK TC-201 尿液化学检测系统
K号: K152835 · 2016-03-07
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决定日期2016-03-07
产品代码JFY
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
URITEK TC-201 URINE CHEMISTRY TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Teco Diagnostics, Inc.. It received FDA 510(k) clearance on 2016-03-07 under 510(k) number K152835. The device is classified under product code JFY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the URITEK TC-201 URINE CHEMISTRY TEST SYSTEM?
URITEK TC-201 URINE CHEMISTRY TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2016-03-07. The listed applicant is Teco Diagnostics, Inc.. The 510(k) number is K152835.
When did URITEK TC-201 URINE CHEMISTRY TEST SYSTEM receive FDA 510(k) clearance?
URITEK TC-201 URINE CHEMISTRY TEST SYSTEM received FDA 510(k) clearance on 2016-03-07, under 510(k) number K152835.
Who is the listed applicant for URITEK TC-201 URINE CHEMISTRY TEST SYSTEM?
The FDA 510(k) record lists Teco Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for URITEK TC-201 URINE CHEMISTRY TEST SYSTEM?
The FDA product code for URITEK TC-201 URINE CHEMISTRY TEST SYSTEM is JFY.
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。
列明Teco 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。
相关器械（代码：JFY）
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。
K252619QSCHECK UISACRQstag, Inc.K212223Atellica CH 酶法肌酐_3 (ECre3)Siemens Healthcare Diagnostics, Inc.K193649优米森C1200肌酐PAPHORIBA ABX SASK182384ACR LAB 尿液分析测试系统Healthy.Io, Ltd.K183555GEM Premier ChemSTATInstrumentation Laboratory COK182038URiSCAN 10ACR 尿试纸，用于 URiSCAN Optima 尿分析仪Yd Diagnostics Corporation
官方来源
在 FDA 数据库中查看 →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。
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