FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FIBRINOGEN FDP CONTROL
K Number: K915503
·
Decision Jan 30, 1992
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
56
Applicant Total
12
Review Days
52
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Basic Information
- Device Name
- FIBRINOGEN FDP CONTROL
- K Number
- K915503
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7320
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cala Diagnostics
- Date Received
- December 9, 1991
- Decision Date
- January 30, 1992
- Product Code
- DAP
- 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 |
|---|---|---|---|
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | FDA class 2 | Hematology |
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Other Clearances by Cala Diagnostics
| K Number | Device Name | ||
|---|---|---|---|
| K944247 | CARDIOCHEX CKMB IMMUNOINHIBITION CONTROL | Oct 31, 1994 | Substantially Equivalent |
| K944246 | CARDIOCHEX CKMB MASS MEASUREMENT CONTROL | Oct 31, 1994 | Substantially Equivalent |
| K944243 | CARDIOCHEX | Oct 27, 1994 | Substantially Equivalent |
| K930874 | LD-1 CONTROL-LEVEL 1 & 2 | Apr 22, 1993 | Substantially Equivalent |
| K930875 | CKMB CONTROL - LEVEL 1,2,3 | Apr 13, 1993 | Substantially Equivalent |
| K930873 | CKMB ISOENZYME CONTROL-LEVEL 1,2.3 | Apr 13, 1993 | Substantially Equivalent |
| K926015 | CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 1,2,3 | Dec 28, 1992 | Substantially Equivalent |
| K912827 | SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3 | Aug 12, 1991 | Substantially Equivalent |
| K912826 | WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2 | Jul 26, 1991 | Substantially Equivalent |
| K864456 | CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3 | May 6, 1987 | Substantially Equivalent |