FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN
K Number: K083260
·
Decision Oct 16, 2009
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
45
Applicant Total
158
Review Days
345
Basic Information
- Device Name
- ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN
- K Number
- K083260
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5680
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics
- Date Received
- November 5, 2008
- Decision Date
- October 16, 2009
- Product Code
- DDR
- Advisory Committee
- Immunology
- 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 |
|---|---|---|---|
| DDR | Myoglobin, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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