FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEPCON(R) CV WHOLE BLOOD COAGULATION CONTROLS
K Number: K894466
·
Decision Sep 5, 1989
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
180
Applicant Total
15
Review Days
49
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Basic Information
- Device Name
- HEPCON(R) CV WHOLE BLOOD COAGULATION CONTROLS
- K Number
- K894466
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Hemotec, Inc.
- Date Received
- July 18, 1989
- Decision Date
- September 5, 1989
- Product Code
- JPA
- 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 |
|---|---|---|---|
| JPA | System, Multipurpose For In Vitro Coagulation Studies | FDA class 2 | Hematology |
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Other Clearances by Hemotec, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K902081 | CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL | Jul 3, 1990 | Substantially Equivalent |
| K894359 | CLOTRAC CITRATED WHOLE BLOOD COAGULATION CONTROLS | Sep 5, 1989 | Substantially Equivalent |
| K894317 | HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS. | Sep 5, 1989 | Substantially Equivalent |
| K884590 | HEPCON/SYSTEM B-10 HEPARIN ASSAY/SCREEN/CARTRIDGES | Jan 10, 1989 | Substantially Equivalent |
| K875089 | HEPCON SYSTEM B-10 ACTIVATED CLOT TIME & HEPARIN | Mar 9, 1988 | Substantially Equivalent |
| K880302 | CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER | Feb 19, 1988 | Substantially Equivalent |
| K854377 | HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS | Dec 4, 1985 | Substantially Equivalent |
| K854376 | HEMOTEC CITRATED WHOLE BLOOD COAGULATION CONTROLS | Dec 4, 1985 | Substantially Equivalent |
| K853789 | ADDITIONAL HEMOTEC HEPCON/SYS B-10 COAGULATION CAR | Oct 4, 1985 | Substantially Equivalent |
| K843459 | HEMOTEC ACT I SYSTEM | Dec 12, 1984 | Substantially Equivalent |