FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COAGULATION CONTROL, LEVEL II
K Number: K870686
·
Decision Apr 20, 1987
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
179
Applicant Total
19
Review Days
60
Basic Information
- Device Name
- COAGULATION CONTROL, LEVEL II
- K Number
- K870686
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- U. S. DIAGNOSTICS, INC.
- Date Received
- February 19, 1987
- Decision Date
- April 20, 1987
- 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 U. S. DIAGNOSTICS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K051651 | G4, MODEL IGM-0004 | Apr 14, 2006 | Substantially Equivalent |
| K870685 | COAGULATION CONTROL, LEVEL I | Apr 20, 1987 | Substantially Equivalent |
| K870687 | COAGULATION CONTROL, LEVEL III | Apr 20, 1987 | Substantially Equivalent |
| K870596 | PROTHROMBIN TIME TEST | Apr 20, 1987 | Substantially Equivalent |
| K871283 | CYANMETHEMOGLOBIN STANDARD | Apr 15, 1987 | Substantially Equivalent |
| K870738 | U.S. DIAGNOSTICS LIQUID CK ISOENZYME CONTROL | Apr 13, 1987 | Substantially Equivalent |
| K870737 | U.S. DIAGNOSTICS LIQUID LD ISOENZYME CONTROL | Apr 13, 1987 | Substantially Equivalent |
| K870684 | LIQUID CHEMISTRY CONTROL, LEVEL I | Apr 6, 1987 | Substantially Equivalent |
| K870683 | LIQUID CHEMISTRY CONTROL, LEVEL II | Apr 6, 1987 | Substantially Equivalent |
| K870688 | O.O2 M CALCIUM CHLORIDE SOLUTION | Mar 31, 1987 | Substantially Equivalent |