FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT
K Number: K123423
·
Decision Jun 5, 2013
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
2
Applicant Total
38
Review Days
211
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Basic Information
- Device Name
- ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT
- K Number
- K123423
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3980
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Meridian Bioscience, Inc.
- Date Received
- November 6, 2012
- Decision Date
- June 5, 2013
- Product Code
- OZX
- 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 |
|---|---|---|---|
| OZX | Mycoplasma Pneumoniae Dna Assay System | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OZX), ordered by most recent decision date.
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FDA 510(k)
FDA Class 2
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illumigene Mycoplasma DNA Amplification Assay
FDA 510(k)
FDA Class 2
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