FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARGOS
K Number: K895127
·
Decision Oct 10, 1989
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
379
Applicant Total
4
Review Days
54
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ARGOS
- K Number
- K895127
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Abx, Inc.
- Date Received
- August 17, 1989
- Decision Date
- October 10, 1989
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GKZ), ordered by most recent decision date.
XR-Series (XR-10, XR-20) Automated Hematology Analyzers
FDA 510(k)
FDA Class 2
·Hematology
Athelas Home
FDA 510(k)
FDA Class 2
·Hematology
Tru Hematology Test
FDA 510(k)
FDA Class 2
·Hematology
Sysmex XR-Series (XR-10) Automated Hematology Analyzer
FDA 510(k)
FDA Class 2
·Hematology
Sysmex XR-Series (XR-20) Automated Hematology Analyzer
FDA 510(k)
FDA Class 2
·Hematology
Alinity h-series System
FDA 510(k)
FDA Class 2
·Hematology