FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PATHFAST D-DIMER
K Number: K072288
·
Decision May 6, 2009
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
27
Applicant Total
4
Review Days
629
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Basic Information
- Device Name
- PATHFAST D-DIMER
- K Number
- K072288
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7320
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mitsubishi Kagaku Iatron
- Date Received
- August 16, 2007
- Decision Date
- May 6, 2009
- 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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