Illumigene C. Difficile, ILLUMIPRO-10 and Illumigene C. Difficile External Control Kit, Models 280050, 610172, 279920
FDA 510(k) K100818 · Meridian Bioscience, Inc.
510(k) numberK100818
Submission
- Device name
- Illumigene C. Difficile, ILLUMIPRO-10 and Illumigene C. Difficile External Control Kit, Models 280050, 610172, 279920
- Applicant
- Meridian Bioscience, Inc.
Cincinnati, OH, US - Received
- March 23, 2010
- Decision date
- July 9, 2010
- 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 |
| K110012 | Illumigene C. Difficile, and ILLUMIPRO-10OMN · Traditional | Meridian Bioscience, Inc. | 02/24/2011SE |
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Questions and answers
When was Illumigene C. Difficile, ILLUMIPRO-10 and Illumigene C. Difficile External Control Kit, Models 280050, 610172, 279920 cleared by the FDA?
Illumigene C. Difficile, ILLUMIPRO-10 and Illumigene C. Difficile External Control Kit, Models 280050, 610172, 279920 (K100818) received a 510(k) decision of Substantially Equivalent on July 9, 2010, 108 days after the submission was received.
What is the product code of K100818?
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.