LIAISON EBV IgM Serum Control Set
K号: K161522 · 2016-06-30
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决定日期2016-06-30
产品代码JJX
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。
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器械摘要
LIAISON EBV IgM Serum Control Set is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2016-06-30 under 510(k) number K161522. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the LIAISON EBV IgM Serum Control Set?
LIAISON EBV IgM Serum Control Set is a medical device that received FDA 510(k) clearance on 2016-06-30. The listed applicant is DiaSorin, Inc.. The 510(k) number is K161522.
When did LIAISON EBV IgM Serum Control Set receive FDA 510(k) clearance?
LIAISON EBV IgM Serum Control Set received FDA 510(k) clearance on 2016-06-30, under 510(k) number K161522.
Who is the listed applicant for LIAISON EBV IgM Serum Control Set?
The FDA 510(k) record lists DiaSorin, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LIAISON EBV IgM Serum Control Set?
The FDA product code for LIAISON EBV IgM Serum Control Set is JJX.
相关临床试验
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列明DiaSorin, 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：JJX）
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。
K170678Beta-CrossLaps CalCheck 5Roche DiagnosticsK162173Elecsys CYFRA 21-1 CalCheck 5Roche DiagnosticsK162514Multichem A1cTechnopath ManufacturingK161874Audit MicroControls Linearity DROP LQ 血糖Aalto Scientific, Ltd.K161526LIAISON CMV IgM Serum Control SetDiaSorin, Inc.K161082IDS-iSYS 17-OH 孕酮控制套件，IDS-iSYS 17-OH 孕酮校准验证器Immunodiagnostic Systems , Ltd.
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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