PYLORISET EIA-G (68926)— 510(k) K971537

Clearance details

Applicant

Orion Diagnostica, Div. Orion Corp.

Product code

Code LYR

Device class

Class 1

Regulation

21 CFR 866.3110

Advisory panel

Microbiology

Date received

1997-04-28

Decision date

1997-06-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Espoo, FI

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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 →