FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
X100 with Full Field Peripheral Blood Smear (PBS) Application
K Number: K201301
·
Decision Oct 2, 2020
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
34
Applicant Total
1
Review Days
140
Basic Information
- Device Name
- X100 with Full Field Peripheral Blood Smear (PBS) Application
- K Number
- K201301
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5260
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Scopio Labs LTD.
- Date Received
- May 15, 2020
- Decision Date
- October 2, 2020
- 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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