FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FACTOR DEFICIENT SUBSTRATE PLASMA VIII
K Number: K840928
·
Decision Apr 30, 1984
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
189
Applicant Total
17
Review Days
59
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Basic Information
- Device Name
- FACTOR DEFICIENT SUBSTRATE PLASMA VIII
- K Number
- K840928
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7290
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Diatech, Inc.
- Date Received
- March 2, 1984
- Decision Date
- April 30, 1984
- Product Code
- GGP
- 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 |
|---|---|---|---|
| GGP | Test, Qualitative And Quantitative Factor Deficiency | FDA class 2 | Hematology |
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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 |