GLP 系统跟踪
K号: K213486 · 2022-03-10
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决定日期2022-03-10
产品代码JGS
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
GLP systems Track is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2022-03-10 under 510(k) number K213486. The device is classified under product code JGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the GLP systems Track?
GLP systems Track is a medical device that received FDA 510(k) clearance on 2022-03-10. The listed applicant is Abbott Laboratories. The 510(k) number is K213486.
When did GLP systems Track receive FDA 510(k) clearance?
GLP systems Track received FDA 510(k) clearance on 2022-03-10, under 510(k) number K213486.
Who is the listed applicant for GLP systems Track?
FDA 510(k)记录显示，申请人为阿伯特实验室。这本身并不能确立该设备的制造商。
What is the FDA product code for GLP systems Track?
The FDA product code for GLP systems Track is JGS.
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Abbott Laboratories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：JGS）
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。
K252475ABL90 FLEX PLUS 系统Radiometer Medicals ApsK230275i-STAT CG8+ 芯片，适用于 i-STAT 1 系统Abbott Point of Care, Inc.K222438A-LYTE® 集成多传感器（IMT Na K Cl）Siemens Healthcare Diagnostics, Inc.K220977ISE 试剂，葡萄糖，CRP 橡胶，DxC 500 AU 临床化学分析仪Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.K200403Stat Profile Prime Plus分析系统Nova Biomedical CorporationK183688i-STAT CHEM8+ 芯片与 i-STAT 1 系统Abbott Point of Care, Inc.
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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