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FDA 510(k)

QUIDEL HELICOBACTER PYLORI TEST

K-Number: K903099 · 1991-04-17

ApplicantQuidel Corp.
Decision Date1991-04-17
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

QUIDEL HELICOBACTER PYLORI 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 1991-04-17 under 510(k) number K903099. 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 QUIDEL HELICOBACTER PYLORI TEST?

QUIDEL HELICOBACTER PYLORI TEST is a medical device that received FDA 510(k) clearance on 1991-04-17. The listed applicant is Quidel Corp.. The 510(k) number is K903099.

When did QUIDEL HELICOBACTER PYLORI TEST receive FDA 510(k) clearance?

QUIDEL HELICOBACTER PYLORI TEST received FDA 510(k) clearance on 1991-04-17, under 510(k) number K903099.

Who is the listed applicant for QUIDEL HELICOBACTER PYLORI 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 QUIDEL HELICOBACTER PYLORI TEST?

The FDA product code for QUIDEL HELICOBACTER PYLORI 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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