B R A H M S PCT敏感KRYPTOR
K号: K171338 · 2017-05-31
广告
器械摘要
B R A H M S PCT sensitive KRYPTOR is the device name listed in this FDA 510(k) record. The listed applicant is Brahms GmbH. It received FDA 510(k) clearance on 2017-05-31 under 510(k) number K171338. The device is classified under product code PRI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the B R A H M S PCT sensitive KRYPTOR?
B R A H M S PCT sensitive KRYPTOR is a medical device that received FDA 510(k) clearance on 2017-05-31. The listed applicant is Brahms GmbH. The 510(k) number is K171338.
When did B R A H M S PCT sensitive KRYPTOR receive FDA 510(k) clearance?
B R A H M S PCT sensitive KRYPTOR received FDA 510(k) clearance on 2017-05-31, under 510(k) number K171338.
Who is the listed applicant for B R A H M S PCT sensitive KRYPTOR?
The FDA 510(k) record lists Brahms GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for B R A H M S PCT sensitive KRYPTOR?
The FDA product code for B R A H M S PCT sensitive KRYPTOR is PRI.
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。
相关器械（代码：PRI）
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。
K220262Dimension EXL LOCI BRAHMS前白蛋白（PCT）Siemens Healthcare Diagnostics, Inc.K192815Elecsys BRAHMS PCTRoche DiagnosticsK173927Elecsys BRAHMS PCTRoche DiagnosticsK173683LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN VerifiersDiaSorin, Inc.K172713Lumipulse G B•R•A•H•M•S PCT 免疫反应卡，Lumipulse G B•R•A•H•M•S PCT 校准器套件Fujirebio Diagnostics,Inc.K170652ARCHITECT B.R.A.H.M.S PCT，ARCHITECT B.R.A.H.M.S PCT校准器，ARCHITECT B.R.A.H.M.S PCT控制品Fisher Diagnostics
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。
广告