FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COBAS INTEGRA CARBON DIOXIDE ASSAY
K Number: K031879
·
Decision Jul 17, 2003
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
85
Applicant Total
264
Review Days
29
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Basic Information
- Device Name
- COBAS INTEGRA CARBON DIOXIDE ASSAY
- K Number
- K031879
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.1160
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics Corp.
- Date Received
- June 18, 2003
- Decision Date
- July 17, 2003
- Product Code
- KHS
- 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 |
|---|---|---|---|
| KHS | Enzymatic, Carbon-Dioxide | FDA class 2 | Clinical Chemistry |
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