PYLORISET DRY— 510(k) K942974

Substantially Equivalent

Orion Diagnostica, Div. Orion Corp.

FDA 510(k) clearance K942974 for PYLORISET DRY, Substantially Equivalent on 1995-04-05. Applicant: Orion Diagnostica, Div. Orion Corp..

Clearance details

Applicant: Orion Diagnostica, Div. Orion Corp.
Product code: Code LYR
Advisory panel: Microbiology
Date received: 1994-06-20
Decision date: 1995-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 02101 Espoo, FI

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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.