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FDA 510(k)

QCA (VERSION 3.1)

K-Number: K031363 · 2004-02-05

ApplicantCell Analysis, Inc.
Decision Date2004-02-05
Product CodeNQN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

QCA (VERSION 3.1) is the device name listed in this FDA 510(k) record. The listed applicant is Cell Analysis, Inc.. It received FDA 510(k) clearance on 2004-02-05 under 510(k) number K031363. The device is classified under product code NQN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QCA (VERSION 3.1)?

QCA (VERSION 3.1) is a medical device that received FDA 510(k) clearance on 2004-02-05. The listed applicant is Cell Analysis, Inc.. The 510(k) number is K031363.

When did QCA (VERSION 3.1) receive FDA 510(k) clearance?

QCA (VERSION 3.1) received FDA 510(k) clearance on 2004-02-05, under 510(k) number K031363.

Who is the listed applicant for QCA (VERSION 3.1)?

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

What is the FDA product code for QCA (VERSION 3.1)?

The FDA product code for QCA (VERSION 3.1) is NQN.

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Official Source

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

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