FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10
K Number: K110012
·
Decision Feb 24, 2011
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
4
Applicant Total
38
Review Days
52
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Basic Information
- Device Name
- ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10
- K Number
- K110012
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Meridian Bioscience, Inc.
- Date Received
- January 3, 2011
- Decision Date
- February 24, 2011
- Product Code
- OMN
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OMN | C. Difficile Nucleic Acid Amplification Test Assay | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OMN), ordered by most recent decision date.
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ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920
FDA 510(k)
FDA Class 1
·Microbiology
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