FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ABACUS 5
K Number: K112755
·
Decision Mar 27, 2012
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
379
Applicant Total
3
Review Days
188
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Basic Information
- Device Name
- ABACUS 5
- K Number
- K112755
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diatron U.S., Inc.
- Date Received
- September 21, 2011
- Decision Date
- March 27, 2012
- 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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