MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714— 510(k) K002023

Substantially Equivalent

Medmira Laboratories, Inc.

FDA 510(k) clearance K002023 for MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714, Substantially Equivalent on 2000-11-13. Applicant: Medmira Laboratories, Inc..

Clearance details

Applicant: Medmira Laboratories, Inc.
Product code: Code LYR
Advisory panel: Microbiology
Date received: 2000-07-03
Decision date: 2000-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Halifax, N.S., CA

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Adverse events under product code LYR

product code LYR

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.