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FDA 510(k)

MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714

K-Number: K002023 · 2000-11-13

ApplicantMedmira Laboratories, Inc.
Decision Date2000-11-13
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714 is the device name listed in this FDA 510(k) record. The listed applicant is Medmira Laboratories, Inc.. It received FDA 510(k) clearance on 2000-11-13 under 510(k) number K002023. 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 MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714?

MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714 is a medical device that received FDA 510(k) clearance on 2000-11-13. The listed applicant is Medmira Laboratories, Inc.. The 510(k) number is K002023.

When did MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714 receive FDA 510(k) clearance?

MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714 received FDA 510(k) clearance on 2000-11-13, under 510(k) number K002023.

Who is the listed applicant for MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714?

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

What is the FDA product code for MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714?

The FDA product code for MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714 is LYR.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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