FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE
K Number: K912357
·
Decision Jul 9, 1991
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
15
Applicant Total
79
Review Days
42
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Basic Information
- Device Name
- 3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE
- K Number
- K912357
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.8150
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- R&D Systems, Inc.
- Date Received
- May 28, 1991
- Decision Date
- July 9, 1991
- Product Code
- KRX
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| KRX | Calibrator For Cell Indices | FDA class 2 | Hematology |
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