FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEPARIN ASSAY CONTROLS
K Number: K103313
·
Decision Dec 1, 2010
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
98
Applicant Total
209
Review Days
21
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Basic Information
- Device Name
- HEPARIN ASSAY CONTROLS
- K Number
- K103313
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic, Inc.
- Date Received
- November 10, 2010
- Decision Date
- December 1, 2010
- 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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