FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
VisuCon-F Low Fibrinogen Control Plasma
K Number: K150144
·
Decision Mar 6, 2016
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
98
Applicant Total
5
Review Days
409
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Basic Information
- Device Name
- VisuCon-F Low Fibrinogen Control Plasma
- K Number
- K150144
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Affinity Biologicals, Inc.
- Date Received
- January 22, 2015
- Decision Date
- March 6, 2016
- 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 Affinity Biologicals, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K110432 | VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN | Oct 20, 2011 | Substantially Equivalent |
| K091284 | VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA | Oct 28, 2009 | Substantially Equivalent |
| K052825 | VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG | Jan 20, 2006 | Substantially Equivalent |
| K051054 | VISULIZE FACTOR IX ANTIGEN KIT | Jun 29, 2005 | Substantially Equivalent |