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FDA 510(k)

SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control

K-Number: K230868 · 2023-04-13

ApplicantMaine Molecular Quality Controls, Inc.
Decision Date2023-04-13
Product CodePMN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control is a medical device manufactured by Maine Molecular Quality Controls, Inc.. It received FDA 510(k) clearance on 2023-04-13 under approval number K230868. The device is classified under product code PMN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control?

SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control is a medical device that received FDA 510(k) clearance on 2023-04-13. It is manufactured by Maine Molecular Quality Controls, Inc.. The 510(k) number is K230868.

When was SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control approved by the FDA?

SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control received FDA 510(k) clearance on 2023-04-13, under approval number K230868.

What company makes SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control?

SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control is manufactured by Maine Molecular Quality Controls, Inc..

What is the FDA product code for SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control?

The FDA product code for SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control is PMN.

Related Clinical Trials

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Related PubMed Literature

PMID: 40775863 Use of the Learning Health System to Redesign and Implement a Clinical Decision Support System for Antimicrobial Stewardship. Studies in health technology and informatics (2025)

Other Devices by Maine Molecular Quality Controls, Inc.

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Related Devices (Code: PMN)

K161573FilmArray RP EZ Control Panel M265Maine Molecular Quality Controls, Inc. K152679Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPakBio-Rad Laboratories DEN150058Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPakBio-Rad Laboratories K173171FilmArray RP2/RP2plus Control PanelMaine Molecular Quality Controls, Inc. K163522FilmArray Warrior Control Panel M290Maine Molecular Quality Controls, Inc. K182472Cepheid Xpert GBS LB Control PanelMicrobiologics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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