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FDA 510(k)

QUICKVUE ONE-STEP H. PYLORI II TEST

K-Number: K991747 · 1999-08-04

ApplicantQuidel Corp.
Decision Date1999-08-04
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

QUICKVUE ONE-STEP H. PYLORI II 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 1999-08-04 under 510(k) number K991747. The device is classified under product code LYR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUICKVUE ONE-STEP H. PYLORI II TEST?

QUICKVUE ONE-STEP H. PYLORI II TEST is a medical device that received FDA 510(k) clearance on 1999-08-04. The listed applicant is Quidel Corp.. The 510(k) number is K991747.

When did QUICKVUE ONE-STEP H. PYLORI II TEST receive FDA 510(k) clearance?

QUICKVUE ONE-STEP H. PYLORI II TEST received FDA 510(k) clearance on 1999-08-04, under 510(k) number K991747.

Who is the listed applicant for QUICKVUE ONE-STEP H. PYLORI II 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 ONE-STEP H. PYLORI II TEST?

The FDA product code for QUICKVUE ONE-STEP H. PYLORI II TEST is LYR.

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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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