FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118
K Number: K072138
·
Decision Dec 21, 2007
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
41
Applicant Total
251
Review Days
141
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Basic Information
- Device Name
- VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118
- K Number
- K072138
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- bioMerieux, Inc.
- Date Received
- August 2, 2007
- Decision Date
- December 21, 2007
- 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 |
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