FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL
K Number: K022046
·
Decision Jul 23, 2002
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
98
Applicant Total
5
Review Days
29
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Basic Information
- Device Name
- VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL
- K Number
- K022046
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vital Scientific N.V.
- Date Received
- June 24, 2002
- Decision Date
- July 23, 2002
- 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 |
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Other Clearances by Vital Scientific N.V.
| K Number | Device Name | ||
|---|---|---|---|
| K022021 | VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT | Nov 1, 2002 | Substantially Equivalent |
| K021976 | FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON | Oct 25, 2002 | Substantially Equivalent |
| K020840 | VITAL SCIENTIFIC PT WITH CALCIUM | May 15, 2002 | Substantially Equivalent |
| K973628 | VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA | Mar 13, 1998 | Substantially Equivalent |