FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONTEXT FILTER
K Number: K791108
·
Decision Jul 17, 1979
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
376
Applicant Total
18
Review Days
33
Basic Information
- Device Name
- CONTEXT FILTER
- K Number
- K791108
- 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
- June 14, 1979
- Decision Date
- July 17, 1979
- 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 |
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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 |
| 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 |
| K761207 | HEMATRAK RBC MORPHOLOGY | Oct 18, 1977 | Substantially Equivalent |
| K770680 | HEMATRAK | Jul 1, 1977 | Substantially Equivalent |
| K770550 | ATYPIA PROFILE MONITOR | Jun 17, 1977 | Substantially Equivalent |