FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PREMIER C. DIFFICILE GDH
K Number: K110620
·
Decision May 3, 2011
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
9
Applicant Total
38
Review Days
61
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Basic Information
- Device Name
- PREMIER C. DIFFICILE GDH
- K Number
- K110620
- 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
- March 3, 2011
- Decision Date
- May 3, 2011
- Product Code
- MCB
- 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 |
|---|---|---|---|
| MCB | Antigen, C. Difficile | FDA class 1 | Microbiology |
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FDA 510(k)
FDA Class 1
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