The following data is part of a premarket notification filed by Meridian Bioscience, Inc. with the FDA for Illumigene C. Difficile, And Illumipro-10.
| Device ID | K110012 |
| 510k Number | K110012 |
| Device Name: | ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10 |
| Classification | C. Difficile Nucleic Acid Amplification Test Assay |
| Applicant | MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Contact | Michelle L Smith |
| Correspondent | Michelle L Smith MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Product Code | OMN |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-03 |
| Decision Date | 2011-02-24 |
| Summary: | summary |