FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CELL-DYN 3000 CONTROL
K Number: K902391
·
Decision Aug 22, 1990
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
11
Applicant Total
73
Review Days
84
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Basic Information
- Device Name
- CELL-DYN 3000 CONTROL
- K Number
- K902391
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.8625
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Unipath , Ltd.
- Date Received
- May 30, 1990
- Decision Date
- August 22, 1990
- Product Code
- JCN
- 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 |
|---|---|---|---|
| JCN | Control, Cell Counter, Normal And Abnormal | FDA class 2 | Hematology |
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