FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 99, VITROS CHEMISTRY PRODUCTS AAT/HPT PERFORMANCE VERIFIER I, II, AND III
K Number: K060940
·
Decision Apr 24, 2006
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
301
Applicant Total
106
Review Days
18
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Basic Information
- Device Name
- VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 99, VITROS CHEMISTRY PRODUCTS AAT/HPT PERFORMANCE VERIFIER I, II, AND III
- K Number
- K060940
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Date Received
- April 6, 2006
- Decision Date
- April 24, 2006
- Product Code
- JIX
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- IM
- 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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