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FDA 510(k)

INTROL CF PANEL I CONTROL, MODEL: G106

K-Number: K083171 · 2008-12-16

ApplicantMaine Molecular Quality Controls, Inc.
Decision Date2008-12-16
Product CodeNZB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

INTROL CF PANEL I CONTROL, MODEL: G106 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 2008-12-16 under 510(k) number K083171. The device is classified under product code NZB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTROL CF PANEL I CONTROL, MODEL: G106?

INTROL CF PANEL I CONTROL, MODEL: G106 is a medical device that received FDA 510(k) clearance on 2008-12-16. The listed applicant is Maine Molecular Quality Controls, Inc.. The 510(k) number is K083171.

When did INTROL CF PANEL I CONTROL, MODEL: G106 receive FDA 510(k) clearance?

INTROL CF PANEL I CONTROL, MODEL: G106 received FDA 510(k) clearance on 2008-12-16, under 510(k) number K083171.

Who is the listed applicant for INTROL CF PANEL I CONTROL, MODEL: G106?

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 INTROL CF PANEL I CONTROL, MODEL: G106?

The FDA product code for INTROL CF PANEL I CONTROL, MODEL: G106 is NZB.

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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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