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FDA 510(k)

INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST

K-Number: K024360 · 2003-06-10

ApplicantAlfa Scientific Designs, Inc.
Decision Date2003-06-10
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST is the device name listed in this FDA 510(k) record. The listed applicant is Alfa Scientific Designs, Inc.. It received FDA 510(k) clearance on 2003-06-10 under 510(k) number K024360. 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 INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST?

INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST is a medical device that received FDA 510(k) clearance on 2003-06-10. The listed applicant is Alfa Scientific Designs, Inc.. The 510(k) number is K024360.

When did INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST receive FDA 510(k) clearance?

INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST received FDA 510(k) clearance on 2003-06-10, under 510(k) number K024360.

Who is the listed applicant for INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST?

The FDA 510(k) record lists Alfa Scientific Designs, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST?

The FDA product code for INSTANT-VIEW H. PYLORI ONE STEP RAPID 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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