FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
DUET SYSTEM
K Number: K040591
·
Decision Sep 16, 2004
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
34
Applicant Total
5
Review Days
192
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Basic Information
- Device Name
- DUET SYSTEM
- K Number
- K040591
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5260
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bioview , Ltd.
- Date Received
- March 8, 2004
- Decision Date
- September 16, 2004
- Product Code
- JOY
- 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 |
|---|---|---|---|
| JOY | Device, Automated Cell-Locating | FDA class 2 | Hematology |
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