FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II
K Number: K142595
·
Decision Jun 4, 2015
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
25
Applicant Total
16
Review Days
262
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Basic Information
- Device Name
- VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II
- K Number
- K142595
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1373
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ortho Clinical Diagnostics
- Date Received
- September 15, 2014
- Decision Date
- June 4, 2015
- Product Code
- PDJ
- 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 |
|---|---|---|---|
| PDJ | Hemoglobin A1c Test System | FDA class 2 | Clinical Chemistry |
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