FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIACELIN
K Number: K840288
·
Decision Apr 23, 1984
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
98
Applicant Total
17
Review Days
90
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
- DIACELIN
- K Number
- K840288
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Diatech, Inc.
- Date Received
- January 24, 1984
- Decision Date
- April 23, 1984
- Product Code
- GGN
- 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 |
|---|---|---|---|
| GGN | Plasma, Coagulation Control | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GGN), ordered by most recent decision date.
VALIDATE D-Dimer Calibration Verification / Linearity Test Kit
FDA 510(k)
FDA Class 2
·Hematology
VALIDATE Heparin Calibration Verification/Linearity Test Kit
FDA 510(k)
FDA Class 2
·Hematology
George King Coumadin Plasma
FDA 510(k)
FDA Class 2
·Hematology
VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit
FDA 510(k)
FDA Class 2
·Hematology
VALIDATE D-Dimer Calibration Verification/Linearity Test Kit
FDA 510(k)
FDA Class 2
·Hematology
VisuCon-F Low Fibrinogen Control Plasma
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by Diatech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K881685 | FIBRINOGENTEST-O | Aug 9, 1988 | Substantially Equivalent |
| K854938 | COASCREENER/DIASCREENERBLOOD PLASMA TIMING INST. | Mar 12, 1986 | Substantially Equivalent |
| K854089 | DIATIMER-1 BLOOD PLASMA CLOT TIMING INSTRUMENT | Jan 6, 1986 | Substantially Equivalent |
| K854090 | DIATIMER-2 BLOOD PLASMA CLOT TIMING INSTRUMENT | Jan 6, 1986 | Substantially Equivalent |
| K842286 | DIA T1, T2 & T3 | Sep 11, 1984 | Substantially Equivalent |
| K841523 | OWREN'S VERONAL BUFFERR | Jun 1, 1984 | Substantially Equivalent |
| K841462 | HEPARIN COAGULATION CONTROL PLASMA 1- | Jun 1, 1984 | Substantially Equivalent |
| K841366 | DIA FIBRIN | Jun 1, 1984 | Substantially Equivalent |
| K841365 | DIA REPTIN | Jun 1, 1984 | Substantially Equivalent |
| K841461 | COAGULATION CONTROL PLASMA LEVEL 1/2/3 | May 2, 1984 | Substantially Equivalent |