Access TPO 抗体
K号: K240469 · 2024-08-09
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决定日期2024-08-09
产品代码JZO
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器械摘要
Access TPO Antibody is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2024-08-09 under 510(k) number K240469. The device is classified under product code JZO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Access TPO Antibody?
Access TPO Antibody is a medical device that received FDA 510(k) clearance on 2024-08-09. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K240469.
When did Access TPO Antibody receive FDA 510(k) clearance?
Access TPO Antibody received FDA 510(k) clearance on 2024-08-09, under 510(k) number K240469.
Who is the listed applicant for Access TPO Antibody?
FDA 510(k)记录中列出Beckman Coulter, Inc.为申请人。这本身并不能确立该设备制造商的身份。
What is the FDA product code for Access TPO Antibody?
The FDA product code for Access TPO Antibody is JZO.
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Beckman Coulter, 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：JZO）
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。
K250250ADVIA Centaur 抗甲状腺过氧化物酶IISiemens Healthcare Diagnostics, Inc.K213517Access 甲状腺球蛋白抗体IIBeckman Coulter, Inc.K222610Elecsys 抗-TgRoche DiagnosticsK193313Elecsys 抗-TSHRRoche DiagnosticsK151799EliA anti-TG 免疫测定，EliA anti-TPO 免疫测定，EliA 甲状腺阳性对照 250，EliA 甲状腺阳性对照 2500/5000Phadia ABK152061IMMULITE 2000 TSI 测定，IMMULITE 2000 TSI 校准验证材料Siemens Healthcare Diagnostics, 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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