i-STAT CHEM8+ 芯片与 i-STAT 1 系统
K号: K191298 · 2020-02-07
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决定日期2020-02-07
产品代码JFL
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
i-STAT CHEM8+ cartridge with the i-STAT 1 System is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Point of Care, Inc.. It received FDA 510(k) clearance on 2020-02-07 under 510(k) number K191298. The device is classified under product code JFL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the i-STAT CHEM8+ cartridge with the i-STAT 1 System?
i-STAT CHEM8+ cartridge with the i-STAT 1 System is a medical device that received FDA 510(k) clearance on 2020-02-07. The listed applicant is Abbott Point of Care, Inc.. The 510(k) number is K191298.
When did i-STAT CHEM8+ cartridge with the i-STAT 1 System receive FDA 510(k) clearance?
i-STAT CHEM8+ cartridge with the i-STAT 1 System received FDA 510(k) clearance on 2020-02-07, under 510(k) number K191298.
Who is the listed applicant for i-STAT CHEM8+ cartridge with the i-STAT 1 System?
The FDA 510(k) record lists Abbott Point of Care, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for i-STAT CHEM8+ cartridge with the i-STAT 1 System?
The FDA product code for i-STAT CHEM8+ cartridge with the i-STAT 1 System is JFL.
相关临床试验
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列明Abbott Point of Care, 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。
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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