FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ROCHE ORAL FLUID COCAINE
K Number: K101160
·
Decision Feb 11, 2011
Classifications
1
FEI Numbers
97
Registration Numbers
97
Same Product Code
144
Applicant Total
183
Review Days
291
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Basic Information
- Device Name
- ROCHE ORAL FLUID COCAINE
- K Number
- K101160
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3250
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics
- Date Received
- April 26, 2010
- Decision Date
- February 11, 2011
- Product Code
- DIO
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | FDA class 2 | Clinical Toxicology |
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