FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5
K Number: K100716
·
Decision Jun 23, 2011
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
98
Applicant Total
35
Review Days
468
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Basic Information
- Device Name
- AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5
- K Number
- K100716
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aalto Scientific, Ltd.
- Date Received
- March 12, 2010
- Decision Date
- June 23, 2011
- Product Code
- GGN
- 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 |
|---|---|---|---|
| GGN | Plasma, Coagulation Control | FDA class 2 | Hematology |
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