ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10— 510(k) K110012
Substantially EquivalentMeridian Bioscience, Inc.
FDA 510(k) clearance K110012 for ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10, Substantially Equivalent on 2011-02-24. Applicant: Meridian Bioscience, Inc.. Device class: 1.
Clearance details
- Applicant
- Meridian Bioscience, Inc.
- Product code
- Code OMN
- Device class
- Class 1
- Regulation
- 21 CFR 866.2660
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cincinnati, OH, US
Recent devices under product code OMN
view allMore clearances from Meridian Bioscience, Inc.
view allRecalls naming K110012
K-number listed on FDA's recall record- Z-0568-2026 — Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay
- Z-1941-2014 — illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. The illumipro-10 incubator/reader is designed to be used with illumigene Molecular Assays. The device incubates illumigene Test Devices and reads endpoint reactions.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110012.
Data sourced from openFDA. This site is unofficial and independent of the FDA.