FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE
K Number: K897060
·
Decision Jan 2, 1990
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
7
Applicant Total
79
Review Days
15
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Basic Information
- Device Name
- CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE
- K Number
- K897060
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.8185
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- R&D Systems, Inc.
- Date Received
- December 18, 1989
- Decision Date
- January 2, 1990
- Product Code
- KSA
- 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 |
|---|---|---|---|
| KSA | Calibrator For Red-Cell And White-Cell Counting | FDA class 2 | Hematology |
Similar 510(k) Clearances
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TRI-COUNT CALIBRATOR
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HEMOTOLOGY CALIBRATOR
FDA 510(k)
FDA Class 2
·Hematology
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