FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA; ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON HITACHI
K Number: K002706
·
Decision Mar 16, 2001
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
56
Applicant Total
264
Review Days
198
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Basic Information
- Device Name
- ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA; ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON HITACHI
- K Number
- K002706
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7320
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics Corp.
- Date Received
- August 30, 2000
- Decision Date
- March 16, 2001
- 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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