FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COBAS INTEGRA ALP IFCC GEN.2
K Number: K033185
·
Decision Oct 14, 2003
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
123
Applicant Total
264
Review Days
13
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Basic Information
- Device Name
- COBAS INTEGRA ALP IFCC GEN.2
- K Number
- K033185
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.1050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics Corp.
- Date Received
- October 1, 2003
- Decision Date
- October 14, 2003
- Product Code
- CJE
- 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 |
|---|---|---|---|
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | FDA class 2 | Clinical Chemistry |
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