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FDA 510(k)

QUICKVUE ADVANCE PH AND AMINES GLL TEST

K-Number: K040008 · 2004-04-29

ApplicantQuidel Corp.
Decision Date2004-04-29
Product CodeCEN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUICKVUE ADVANCE PH AND AMINES GLL TEST is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corp.. It received FDA 510(k) clearance on 2004-04-29 under 510(k) number K040008. The device is classified under product code CEN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUICKVUE ADVANCE PH AND AMINES GLL TEST?

QUICKVUE ADVANCE PH AND AMINES GLL TEST is a medical device that received FDA 510(k) clearance on 2004-04-29. The listed applicant is Quidel Corp.. The 510(k) number is K040008.

When did QUICKVUE ADVANCE PH AND AMINES GLL TEST receive FDA 510(k) clearance?

QUICKVUE ADVANCE PH AND AMINES GLL TEST received FDA 510(k) clearance on 2004-04-29, under 510(k) number K040008.

Who is the listed applicant for QUICKVUE ADVANCE PH AND AMINES GLL TEST?

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

What is the FDA product code for QUICKVUE ADVANCE PH AND AMINES GLL TEST?

The FDA product code for QUICKVUE ADVANCE PH AND AMINES GLL TEST is CEN.

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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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