PYLORIPROBE— 510(k) K981396

Substantially Equivalent

Amdl, Inc.

FDA 510(k) clearance K981396 for PYLORIPROBE, Substantially Equivalent on 1998-07-30. Applicant: Amdl, Inc..

Clearance details

Applicant: Amdl, Inc.
Product code: Code LYR
Advisory panel: Microbiology
Date received: 1998-04-17
Decision date: 1998-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tustin, CA, US

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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.