PhAST仪器和PhAST阴性菌血培养板
K号: K253316 · 2026-06-26
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器械摘要
PhAST instrument and PhAST Blood Culture Gram-negative Panel is the device name listed in this FDA 510(k) record. The listed applicant is Phast Corp.. It received FDA 510(k) clearance on 2026-06-26 under 510(k) number K253316. The device is classified under product code SAN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the PhAST instrument and PhAST Blood Culture Gram-negative Panel?
PhAST instrument and PhAST Blood Culture Gram-negative Panel is a medical device that received FDA 510(k) clearance on 2026-06-26. The listed applicant is Phast Corp.. The 510(k) number is K253316.
When did PhAST instrument and PhAST Blood Culture Gram-negative Panel receive FDA 510(k) clearance?
PhAST instrument and PhAST Blood Culture Gram-negative Panel received FDA 510(k) clearance on 2026-06-26, under 510(k) number K253316.
Who is the listed applicant for PhAST instrument and PhAST Blood Culture Gram-negative Panel?
The FDA 510(k) record lists Phast Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PhAST instrument and PhAST Blood Culture Gram-negative Panel?
The FDA product code for PhAST instrument and PhAST Blood Culture Gram-negative Panel is SAN.
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：SAN）
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。
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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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