ACCUSTAT H. PYLORI ONE STEP TEST— 510(k) K973523

Name: FDA 510(k) clearance K973523
Creator: U.S. Food and Drug Administration
Published: 1998-03-03

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K973523 for ACCUSTAT H. PYLORI ONE STEP TEST, Substantially Equivalent on 1998-03-03. Applicant: Boehringer Mannheim Corp.. Device class: 1.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code LYR
Device class: Class 1
Regulation: 21 CFR 866.3110
Advisory panel: Microbiology
Date received: 1997-09-17
Decision date: 1998-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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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.