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FDA 510(k)

SPOTFIRE RSP 正负对照 (M425), SPOTFIRE RSP 阳性对照 (M42638), SPOTFIRE RSP 阴性对照 (M42738)

K号: K233611 · 2024-03-26

申请人Maine Molecular Quality Controls, Inc.
决定日期2024-03-26
产品代码PMN
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决定实质等同

器械摘要

SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738) is the device name listed in this FDA 510(k) record. The listed applicant is Maine Molecular Quality Controls, Inc.. It received FDA 510(k) clearance on 2024-03-26 under 510(k) number K233611. The device is classified under product code PMN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)?

SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738) is a medical device that received FDA 510(k) clearance on 2024-03-26. The listed applicant is Maine Molecular Quality Controls, Inc.. The 510(k) number is K233611.

When did SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738) receive FDA 510(k) clearance?

SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738) received FDA 510(k) clearance on 2024-03-26, under 510(k) number K233611.

Who is the listed applicant for SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)?

The FDA 510(k) record lists Maine Molecular Quality Controls, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)?

The FDA product code for SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738) is PMN.

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Maine Molecular Quality Controls, 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。

K260577FilmArray TF 控制板 M527K251526FilmArray 胃肠道控制面板 M238K241289SPOTFIRE RSP 正负对照; SPOTFIRE RSP 阴性对照K230868SPOTFIRE® RSP 正负对照, SPOTFIRE® RSP 阳性对照, SPOTFIRE® RSP 阴性对照K221253SPOTFIRE RSP 阳性对照, SPOTFIRE RSP 阴性对照K203680BioFire JI 控制面板 M420

查看所有 13 个设备 →

相关器械（代码：PMN）

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。

K261475BIOFIRE® FILMARRAY® 热带发热检测控制试剂盒Biofire Defense, LLCK260577FilmArray TF 控制板 M527Maine Molecular Quality Controls, Inc.K260041MDx-Chex 用于 BCPStreck, LLCK254166MDx-Chex 用于 BCNStreckK254167MDx-Chex 用于 BCYStreck, LLCK251526FilmArray 胃肠道控制面板 M238Maine Molecular Quality Controls, Inc.

官方来源

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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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