FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FIBROTEK FIB
K Number: K042919
·
Decision Nov 29, 2004
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
12
Applicant Total
10
Review Days
38
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Basic Information
- Device Name
- FIBROTEK FIB
- K Number
- K042919
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7340
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- R2 Diagnostics, Inc.
- Date Received
- October 22, 2004
- Decision Date
- November 29, 2004
- Product Code
- GIS
- 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 |
|---|---|---|---|
| GIS | Test, Fibrinogen | FDA class 2 | Hematology |
Similar 510(k) Clearances
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Other Clearances by R2 Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K102908 | NOFACT IX | Dec 19, 2011 | Substantially Equivalent |
| 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 |
| K040296 | PHOSPHOPLASTIN RL | May 24, 2004 | Substantially Equivalent |
| K033471 | PHOSPHOLIN ES AND CALCIUM CHLORIDE | Feb 4, 2004 | Substantially Equivalent |