FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
XPERT C. DIFFICILE
K Number: K091109
·
Decision Jul 9, 2009
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
41
Applicant Total
50
Review Days
84
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Basic Information
- Device Name
- XPERT C. DIFFICILE
- K Number
- K091109
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cepheid
- Date Received
- April 16, 2009
- Decision Date
- July 9, 2009
- Product Code
- LLH
- 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 |
|---|---|---|---|
| LLH | Reagents, Clostridium Difficile Toxin | FDA class 1 | Microbiology |
Similar 510(k) Clearances
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| K212213 | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System | Feb 9, 2022 | Substantially Equivalent |