K110012 is an FDA 510(k) clearance for the ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10. This device is classified as a C. Difficile Nucleic Acid Amplification Test Assay (Class I - General Controls, product code OMN).
Submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on February 24, 2011, 52 days after receiving the submission on January 3, 2011.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660. In Vitro Diagnostic Test For The Qualitative Detection Of Toxigenic Clostridium Difficile Nucleic Acids Isolated And Purified From Stool Specimens Obtained From Symptomatic Patients..
| 510(k) Number | K110012 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 03, 2011 |
| Decision Date | February 24, 2011 |
| Days to Decision | 52 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | OMN — C. Difficile Nucleic Acid Amplification Test Assay |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |
| Definition | In Vitro Diagnostic Test For The Qualitative Detection Of Toxigenic Clostridium Difficile Nucleic Acids Isolated And Purified From Stool Specimens Obtained From Symptomatic Patients. |