Elecsys 抗-TSHR
K号: K193313 · 2020-02-27
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决定日期2020-02-27
产品代码JZO
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器械摘要
Elecsys Anti-TSHR is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2020-02-27 under 510(k) number K193313. 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 Elecsys Anti-TSHR?
Elecsys Anti-TSHR is a medical device that received FDA 510(k) clearance on 2020-02-27. The listed applicant is Roche Diagnostics. The 510(k) number is K193313.
When did Elecsys Anti-TSHR receive FDA 510(k) clearance?
Elecsys Anti-TSHR received FDA 510(k) clearance on 2020-02-27, under 510(k) number K193313.
Who is the listed applicant for Elecsys Anti-TSHR?
FDA 510(k)记录显示罗氏诊断公司为申请人。这本身并不能确立该设备的制造商。
What is the FDA product code for Elecsys Anti-TSHR?
The FDA product code for Elecsys Anti-TSHR 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Roche Diagnostics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.K240469Access TPO 抗体Beckman Coulter, Inc.K213517Access 甲状腺球蛋白抗体IIBeckman Coulter, Inc.K222610Elecsys 抗-TgRoche 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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