FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IVOS ANALYZER
K Number: K920719
·
Decision Jun 29, 1992
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
129
Applicant Total
5
Review Days
132
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
- IVOS ANALYZER
- K Number
- K920719
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5200
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Hamilton Thorne Research
- Date Received
- February 18, 1992
- Decision Date
- June 29, 1992
- Product Code
- GKL
- 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 |
|---|---|---|---|
| GKL | Counter, Cell, Automated (Particle Counter) | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GKL), ordered by most recent decision date.
Glocyte Automated Cell Counter System
FDA 510(k)
FDA Class 2
·Hematology
IQ 200 URINE ANALIZER BODY FLUIDS MODULE
FDA 510(k)
FDA Class 2
·Hematology
HEMOCUE WBC SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
IQ 200 URINE ANALYZER BODY FLUIDS MODULE
FDA 510(k)
FDA Class 2
·Hematology
SYSMEX POCH-100I
FDA 510(k)
FDA Class 2
·Hematology