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FDA 510(k)

PYLORISCREEN

K-Number: K925190 · 1993-03-23

ApplicantNew Horizons Diagnostics Co.
Decision Date1993-03-23
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PYLORISCREEN is the device name listed in this FDA 510(k) record. The listed applicant is New Horizons Diagnostics Co.. It received FDA 510(k) clearance on 1993-03-23 under 510(k) number K925190. 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 PYLORISCREEN?

PYLORISCREEN is a medical device that received FDA 510(k) clearance on 1993-03-23. The listed applicant is New Horizons Diagnostics Co.. The 510(k) number is K925190.

When did PYLORISCREEN receive FDA 510(k) clearance?

PYLORISCREEN received FDA 510(k) clearance on 1993-03-23, under 510(k) number K925190.

Who is the listed applicant for PYLORISCREEN?

The FDA 510(k) record lists New Horizons Diagnostics Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PYLORISCREEN?

The FDA product code for PYLORISCREEN is LYR.

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Other records listing New Horizons Diagnostics Co. 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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