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FDA 510(k)

SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control

K-Number: K221253 · 2023-02-03

ApplicantMaine Molecular Quality Controls, Inc.
Decision Date2023-02-03
Product CodePMN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

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 2023-02-03 under approval number K221253. 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 Positive Control, SPOTFIRE RSP Negative Control?

SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control is a medical device that received FDA 510(k) clearance on 2023-02-03. It is manufactured by Maine Molecular Quality Controls, Inc.. The 510(k) number is K221253.

When was SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control approved by the FDA?

SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control received FDA 510(k) clearance on 2023-02-03, under approval number K221253.

What company makes SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control?

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 Positive Control, SPOTFIRE RSP Negative Control?

The FDA product code for SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control is PMN.

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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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