FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM
K Number: K063144
·
Decision Nov 13, 2006
Classifications
1
FEI Numbers
174
Registration Numbers
174
Same Product Code
207
Applicant Total
106
Review Days
28
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Basic Information
- Device Name
- VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM
- K Number
- K063144
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 862.2160
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Date Received
- October 16, 2006
- Decision Date
- November 13, 2006
- Product Code
- JJE
- 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 |
|---|---|---|---|
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | FDA class 1 | Clinical Chemistry |
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