FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDICOUNT DEKA HEMATOLOGY ANALYZER
K Number: K942525
·
Decision Jun 5, 1996
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
379
Applicant Total
5
Review Days
740
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Basic Information
- Device Name
- MEDICOUNT DEKA HEMATOLOGY ANALYZER
- K Number
- K942525
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cea America Corp.
- Date Received
- May 27, 1994
- Decision Date
- June 5, 1996
- 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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Other Clearances by Cea America Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K834614 | WILCOR-XR RP-L MEDICAL FILM | Mar 5, 1984 | Substantially Equivalent |
| K834613 | WILCOR-XR RP MEDICAL FILM | Mar 5, 1984 | Substantially Equivalent |
| K834612 | WILCOR-XR RP-OG MEDICAL FILM | Feb 27, 1984 | Substantially Equivalent |
| K834611 | SINGUL-XR RP NON SCREEN MED. FILM | Feb 21, 1984 | Substantially Equivalent |