FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NOFACT IX
K Number: K102908
·
Decision Dec 19, 2011
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
78
Applicant Total
10
Review Days
444
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Basic Information
- Device Name
- NOFACT IX
- K Number
- K102908
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7290
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- R2 Diagnostics, Inc.
- Date Received
- October 1, 2010
- Decision Date
- December 19, 2011
- Product Code
- GJT
- 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 |
|---|---|---|---|
| GJT | Plasma, Coagulation Factor Deficient | FDA class 2 | Hematology |
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HEMOSIL FACTOR XII DEFICIENT PLASMA
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Other Clearances by R2 Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K102851 | NOFACT VIII | Dec 19, 2011 | Substantially Equivalent |
| K090105 | LUPOTEK KCT | Dec 30, 2010 | Substantially Equivalent |
| K083878 | LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA | Jun 25, 2010 | Substantially Equivalent |
| K082631 | THROMBO TEK PSE, MODEL 90-480 | Dec 17, 2008 | Substantially Equivalent |
| K062306 | PLASMACON N, PLASMACON L-1, PLASMACON L-2 | Mar 16, 2007 | Substantially Equivalent |
| K050817 | T-TEK | Dec 12, 2005 | Substantially Equivalent |
| K042919 | FIBROTEK FIB | Nov 29, 2004 | Substantially Equivalent |
| K040296 | PHOSPHOPLASTIN RL | May 24, 2004 | Substantially Equivalent |
| K033471 | PHOSPHOLIN ES AND CALCIUM CHLORIDE | Feb 4, 2004 | Substantially Equivalent |