FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STERILE, DISPOSABLE CENTRIFUGE BOWL
K Number: K791106
·
Decision Aug 10, 1979
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
9
Applicant Total
206
Review Days
58
Basic Information
- Device Name
- STERILE, DISPOSABLE CENTRIFUGE BOWL
- K Number
- K791106
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.9245
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- TRAVENOL LABORATORIES, S.A.
- Date Received
- June 13, 1979
- Decision Date
- August 10, 1979
- Product Code
- GKT
- 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 |
|---|---|---|---|
| GKT | Separator, Automated, Blood Cell, Diagnostic | FDA class 2 | Hematology |
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|---|---|---|---|
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| K871471 | CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15 | Jun 12, 1987 | Substantially Equivalent |
| K865029 | CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER | Apr 17, 1987 | Substantially Equivalent |