FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ONLINE DAT PROPOXYPHENE PLUS
K Number: K043303
·
Decision Mar 11, 2005
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
21
Applicant Total
264
Review Days
101
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Basic Information
- Device Name
- ONLINE DAT PROPOXYPHENE PLUS
- K Number
- K043303
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3700
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics Corp.
- Date Received
- November 30, 2004
- Decision Date
- March 11, 2005
- Product Code
- JXN
- 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 |
|---|---|---|---|
| JXN | Enzyme Immunoassay, Propoxyphene | FDA class 2 | Clinical Toxicology |
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