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FDA 510(k)

INFINITI SYSTEM

K-Number: K060564 · 2007-02-07

ApplicantAutoGenomics, Inc.
Decision Date2007-02-07
Product CodeNPQ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

INFINITI SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is AutoGenomics, Inc.. It received FDA 510(k) clearance on 2007-02-07 under 510(k) number K060564. The device is classified under product code NPQ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFINITI SYSTEM?

INFINITI SYSTEM is a medical device that received FDA 510(k) clearance on 2007-02-07. The listed applicant is AutoGenomics, Inc.. The 510(k) number is K060564.

When did INFINITI SYSTEM receive FDA 510(k) clearance?

INFINITI SYSTEM received FDA 510(k) clearance on 2007-02-07, under 510(k) number K060564.

Who is the listed applicant for INFINITI SYSTEM?

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

What is the FDA product code for INFINITI SYSTEM?

The FDA product code for INFINITI SYSTEM is NPQ.

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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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