VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192— 510(k) K001460

Clearance details

Applicant

bioMerieux, Inc.

Product code

Code LYR

Device class

Class 1

Regulation

21 CFR 866.3110

Advisory panel

Microbiology

Date received

2000-05-10

Decision date

2000-10-04

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Rockland, MA, US

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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 →