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FDA 510(k)

QUICKVUE ONE-STEP HELICOBACTOR PYLORI TEST

K-Number: K952517 · 1996-02-06

ApplicantQuidel Corp.
Decision Date1996-02-06
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

QUICKVUE ONE-STEP HELICOBACTOR 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 1996-02-06 under 510(k) number K952517. 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 HELICOBACTOR PYLORI TEST?

QUICKVUE ONE-STEP HELICOBACTOR PYLORI TEST is a medical device that received FDA 510(k) clearance on 1996-02-06. The listed applicant is Quidel Corp.. The 510(k) number is K952517.

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

QUICKVUE ONE-STEP HELICOBACTOR PYLORI TEST received FDA 510(k) clearance on 1996-02-06, under 510(k) number K952517.

Who is the listed applicant for QUICKVUE ONE-STEP HELICOBACTOR 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 QUICKVUE ONE-STEP HELICOBACTOR PYLORI TEST?

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

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Other records listing Quidel Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: 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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