PYLORITRAK— 510(k) K912215

Name: FDA 510(k) clearance K912215
Creator: U.S. Food and Drug Administration
Published: 1991-10-04

Substantially Equivalent

Bainbridge Laboratories, Inc.

FDA 510(k) clearance K912215 for PYLORITRAK, Substantially Equivalent on 1991-10-04. Applicant: Bainbridge Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Bainbridge Laboratories, Inc.
Product code: Code LYR
Device class: Class 1
Regulation: 21 CFR 866.3110
Advisory panel: Microbiology
Date received: 1991-05-20
Decision date: 1991-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bainbridge Island, WA, 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.