FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
GenePOC CDiff
K Number: K172569
·
Decision Nov 22, 2017
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
16
Applicant Total
5
Review Days
89
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Basic Information
- Device Name
- GenePOC CDiff
- K Number
- K172569
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3130
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Genepoc, Inc.
- Date Received
- August 25, 2017
- Decision Date
- November 22, 2017
- Product Code
- OZN
- 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 |
|---|---|---|---|
| OZN | C. Difficile Toxin Gene Amplification Assay | FDA class 2 | Microbiology |
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