FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202
K Number: K050365
·
Decision Dec 27, 2005
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
189
Applicant Total
6
Review Days
316
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Basic Information
- Device Name
- BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202
- K Number
- K050365
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7290
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hyphen Biomed
- Date Received
- February 14, 2005
- Decision Date
- December 27, 2005
- Product Code
- GGP
- 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 |
|---|---|---|---|
| GGP | Test, Qualitative And Quantitative Factor Deficiency | FDA class 2 | Hematology |
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Other Clearances by Hyphen Biomed
| K Number | Device Name | ||
|---|---|---|---|
| K071255 | ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A | Sep 7, 2007 | Substantially Equivalent |
| K050367 | BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6 | May 24, 2006 | Substantially Equivalent |
| K051472 | BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR | Dec 23, 2005 | Substantially Equivalent |
| K043007 | BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105 | Nov 7, 2005 | Substantially Equivalent |
| K043451 | BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR | Mar 17, 2005 | Substantially Equivalent |