FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INNOVANCE D-DIMER, MODEL OPBP09
K Number: K093626
·
Decision Nov 29, 2010
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
56
Applicant Total
92
Review Days
370
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Basic Information
- Device Name
- INNOVANCE D-DIMER, MODEL OPBP09
- K Number
- K093626
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7320
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens Healthcare Diagnostics
- Date Received
- November 24, 2009
- Decision Date
- November 29, 2010
- Product Code
- DAP
- 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 |
|---|---|---|---|
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | FDA class 2 | Hematology |
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