FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL
K Number: K070453
·
Decision Jun 11, 2007
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
27
Applicant Total
3
Review Days
115
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Basic Information
- Device Name
- OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL
- K Number
- K070453
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7320
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Olympus Life & Material Science Europa GmbH (Irish
- Date Received
- February 16, 2007
- Decision Date
- June 11, 2007
- Product Code
- GHH
- 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 |
|---|---|---|---|
| GHH | Fibrin Split Products | FDA class 2 | Hematology |
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