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FDA 510(k)

SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control

K-Number: K241289 · 2024-05-30

ApplicantMaine Molecular Quality Controls, Inc.
Decision Date2024-05-30
Product CodePMN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control is a medical device manufactured by Maine Molecular Quality Controls, Inc.. It received FDA 510(k) clearance on 2024-05-30 under approval number K241289. 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 Negative Control?

SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control is a medical device that received FDA 510(k) clearance on 2024-05-30. It is manufactured by Maine Molecular Quality Controls, Inc.. The 510(k) number is K241289.

When was SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control approved by the FDA?

SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control received FDA 510(k) clearance on 2024-05-30, under approval number K241289.

What company makes SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control?

SPOTFIRE RSP Pos & Neg Controls; 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 Negative Control?

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

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Related Devices (Code: PMN)

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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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