FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMATOLOGY CALIBRATOR CONTROL
K Number: K854166
·
Decision Mar 12, 1986
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
24
Applicant Total
4
Review Days
148
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Basic Information
- Device Name
- HEMATOLOGY CALIBRATOR CONTROL
- K Number
- K854166
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.8165
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Interscience Diagnostics, Inc.
- Date Received
- October 15, 1985
- Decision Date
- March 12, 1986
- Product Code
- KRZ
- 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 |
|---|---|---|---|
| KRZ | Calibrator For Hemoglobin And Hematocrit Measurement | FDA class 2 | Hematology |
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