FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TERUMO IMUGARD
K Number: K790105
·
Decision May 24, 1979
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
9
Applicant Total
31
Review Days
128
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
- TERUMO IMUGARD
- K Number
- K790105
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.9245
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Terumo America, Inc.
- Date Received
- January 16, 1979
- Decision Date
- May 24, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GKT), ordered by most recent decision date.
AMICUS Separator System
FDA 510(k)
FDA Class 2
·Hematology
AMICUS Separator System, AMICUS Separator System; Refurbished
FDA 510(k)
FDA Class 2
·Hematology
AUTOMATED BLOOD CELL SEPARATOR
FDA 510(k)
FDA Class 2
·Hematology
AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR
FDA 510(k)
FDA Class 2
·Hematology
CELLTRIFUGE II
FDA 510(k)
FDA Class 2
·Hematology
STERILE, DISPOSABLE CENTRIFUGE BOWL
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by Terumo America, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K811523 | PLASMA FLEX | Sep 9, 1981 | Substantially Equivalent |
| K802970 | TERUMO HOLLOW FIBER OXYGENATOR | Jan 22, 1981 | Substantially Equivalent |
| K802441 | CLIRANS TH10 HOLLOW FIBER DIALYZER | Dec 18, 1980 | Substantially Equivalent |
| K802122 | CLIRANS TH13 HOLLOW FIBER DIALYZER | Dec 18, 1980 | Substantially Equivalent |
| K801192 | CLIRANS TE10 HOLLOW FIBER DIALYZER | Aug 12, 1980 | Substantially Equivalent |
| K801193 | CLIRANS TE15 HOLLOW FIBER DIALYZER | Aug 12, 1980 | Substantially Equivalent |
| K801194 | CLIRANS TE07 HOLLOW FIBER DIALYZER | Aug 12, 1980 | Substantially Equivalent |
| K791411 | COAXIAL DUAL FLOW CATHETER | Nov 13, 1979 | Substantially Equivalent |
| K791173 | SURFLO INJECTION PLUG | Jul 30, 1979 | Substantially Equivalent |
| K772362 | AVF SET FOR SINGLE NEEDLE HEMODIALYSIS | Mar 17, 1978 | Substantially Equivalent |