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FDA 510(k)

QUIDEL QUICKVUE H. PYLORI CONTROLS (POS. AND NEG)

K-Number: K915851 · 1992-02-21

ApplicantQuidel Corp.
Decision Date1992-02-21
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

QUIDEL QUICKVUE H. PYLORI CONTROLS (POS. AND NEG) is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corp.. It received FDA 510(k) clearance on 1992-02-21 under 510(k) number K915851. 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 QUICKVUE H. PYLORI CONTROLS (POS. AND NEG)?

QUIDEL QUICKVUE H. PYLORI CONTROLS (POS. AND NEG) is a medical device that received FDA 510(k) clearance on 1992-02-21. The listed applicant is Quidel Corp.. The 510(k) number is K915851.

When did QUIDEL QUICKVUE H. PYLORI CONTROLS (POS. AND NEG) receive FDA 510(k) clearance?

QUIDEL QUICKVUE H. PYLORI CONTROLS (POS. AND NEG) received FDA 510(k) clearance on 1992-02-21, under 510(k) number K915851.

Who is the listed applicant for QUIDEL QUICKVUE H. PYLORI CONTROLS (POS. AND NEG)?

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 QUICKVUE H. PYLORI CONTROLS (POS. AND NEG)?

The FDA product code for QUIDEL QUICKVUE H. PYLORI CONTROLS (POS. AND NEG) is LYR.

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Other records listing Quidel Corp. as applicant

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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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