FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COBAS INTEGRA C 111
K Number: K063744
·
Decision Jan 17, 2007
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
234
Applicant Total
3
Review Days
30
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Basic Information
- Device Name
- COBAS INTEGRA C 111
- K Number
- K063744
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.1110
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rochdiag
- Date Received
- December 18, 2006
- Decision Date
- January 17, 2007
- Product Code
- CIG
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| CIG | Diazo Colorimetry, Bilirubin | FDA class 2 | Clinical Chemistry |
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