FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VITROS CHEMISTRY PRODUCTS ECO2 SLIDES
K Number: K120765
·
Decision Oct 24, 2012
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
85
Applicant Total
106
Review Days
225
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Basic Information
- Device Name
- VITROS CHEMISTRY PRODUCTS ECO2 SLIDES
- K Number
- K120765
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.1160
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Date Received
- March 13, 2012
- Decision Date
- October 24, 2012
- 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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