FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMATRAK RBC MORPHOLOGY
K Number: K761207
·
Decision Oct 18, 1977
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
379
Applicant Total
18
Review Days
315
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
- HEMATRAK RBC MORPHOLOGY
- K Number
- K761207
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Geometric Data, Div. Smithkline Corp.
- Date Received
- December 7, 1976
- Decision Date
- October 18, 1977
- 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
Other Clearances by Geometric Data, Div. Smithkline Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K841852 | AUTOLYZER 800 | Sep 5, 1984 | Substantially Equivalent |
| K811534 | HEMASPINNER | Aug 18, 1981 | Substantially Equivalent |
| K791041 | HEMATRAK ABNORMAL RECOGNITION | Sep 4, 1979 | Substantially Equivalent |
| K791108 | CONTEXT FILTER | Jul 17, 1979 | Substantially Equivalent |
| K790816 | HEMATRAK MODEL 480 | Jul 17, 1979 | Substantially Equivalent |
| K790042 | STAIN, HEMASTAIN RETIC | Feb 15, 1979 | Substantially Equivalent |
| K780577 | PLATELETS/CU MM | May 19, 1978 | Substantially Equivalent |
| K772139 | RE-CELL SLIDE RECAP | Jan 5, 1978 | Substantially Equivalent |
| K770680 | HEMATRAK | Jul 1, 1977 | Substantially Equivalent |
| K770550 | ATYPIA PROFILE MONITOR | Jun 17, 1977 | Substantially Equivalent |