Illumigene C. Difficile, and ILLUMIPRO-10
FDA 510(k) K110012 · Meridian Bioscience, Inc.
510(k) numberK110012
Submission
- Device name
- Illumigene C. Difficile, and ILLUMIPRO-10
- Applicant
- Meridian Bioscience, Inc.
Cincinnati, OH, US - Received
- January 3, 2011
- Decision date
- February 24, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OMN – C. Difficile Nucleic Acid Amplification Test Assay
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
In vitro diagnostic test for the qualitative detection of toxigenic clostridium difficile nucleic acids isolated and purified from stool specimens obtained from symptomatic patients.
Other 510(k)s with product code OMN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K113433 | Simplexa C. Difficile Universal DirectOMN · Traditional | Focus Diagnostics, Inc. | 04/04/2012SE |
| K110203 | Xpert C. Difficle/Epi AssayOMN · Traditional | Cepheid | 04/07/2011SE |
| K100818 | Illumigene C. Difficile, ILLUMIPRO-10 and Illumigene C. Difficile External Control Kit…OMN · Traditional | Meridian Bioscience, Inc. | 07/09/2010SE |
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Questions and answers
When was Illumigene C. Difficile, and ILLUMIPRO-10 cleared by the FDA?
Illumigene C. Difficile, and ILLUMIPRO-10 (K110012) received a 510(k) decision of Substantially Equivalent on February 24, 2011, 52 days after the submission was received.
What is the product code of K110012?
The FDA product code is OMN – C. Difficile Nucleic Acid Amplification Test Assay, a Class I (low risk) device regulated under 21 CFR 866.2660.