FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NAVIOS FLOW CYTOMETER SYSTEM
K Number: K130373
·
Decision Sep 18, 2013
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
7
Applicant Total
199
Review Days
216
Basic Information
- Device Name
- NAVIOS FLOW CYTOMETER SYSTEM
- K Number
- K130373
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BECKMAN COULTER, INC.
- Date Received
- February 14, 2013
- Decision Date
- September 18, 2013
- Product Code
- OYE
- 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 |
|---|---|---|---|
| OYE | Flow Cytometric Reagents And Accessories. | FDA class 2 | Hematology |
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