FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS)
K Number: K033501
·
Decision Nov 20, 2003
Classifications
1
FEI Numbers
107
Registration Numbers
107
Same Product Code
301
Applicant Total
264
Review Days
15
Basic Information
- Device Name
- MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS)
- K Number
- K033501
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ROCHE DIAGNOSTICS CORP.
- Date Received
- November 5, 2003
- Decision Date
- November 20, 2003
- Product Code
- JIX
- 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 |
|---|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | FDA class 2 | Clinical Chemistry |
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