FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ONLINE DAT BARBITURATES PLUS
K Number: K043211
·
Decision Dec 29, 2004
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
99
Applicant Total
264
Review Days
40
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Basic Information
- Device Name
- ONLINE DAT BARBITURATES PLUS
- K Number
- K043211
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3150
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics Corp.
- Date Received
- November 19, 2004
- Decision Date
- December 29, 2004
- Product Code
- DIS
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| DIS | Enzyme Immunoassay, Barbiturate | FDA class 2 | Clinical Toxicology |
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