FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8
K Number: K844897
·
Decision Mar 22, 1985
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
191
Applicant Total
5
Review Days
95
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Basic Information
- Device Name
- HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8
- K Number
- K844897
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.8625
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Medical Specialties Laboratories
- Date Received
- December 17, 1984
- Decision Date
- March 22, 1985
- Product Code
- JPK
- 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 |
|---|---|---|---|
| JPK | Mixture, Hematology Quality Control | FDA class 2 | Hematology |
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