FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PREMIER CAMPY, MODEL 618096
K Number: K083464
·
Decision Jan 30, 2009
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
11
Applicant Total
38
Review Days
67
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Basic Information
- Device Name
- PREMIER CAMPY, MODEL 618096
- K Number
- K083464
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3110
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Meridian Bioscience, Inc.
- Date Received
- November 24, 2008
- Decision Date
- January 30, 2009
- Product Code
- LQP
- 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 |
|---|---|---|---|
| LQP | Campylobacter Spp. | FDA class 1 | Microbiology |
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