FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COULTER COUNTER MODEL S-PLUS V
K Number: K833600
·
Decision Jan 10, 1984
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
376
Applicant Total
101
Review Days
90
Basic Information
- Device Name
- COULTER COUNTER MODEL S-PLUS V
- K Number
- K833600
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- COULTER ELECTRONICS, INC.
- Date Received
- October 12, 1983
- Decision Date
- January 10, 1984
- Product Code
- GKZ
- 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 |
|---|---|---|---|
| GKZ | Counter, Differential Cell | FDA class 2 | Hematology |
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