FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE)
K Number: K090563
·
Decision Oct 9, 2009
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
98
Applicant Total
300
Review Days
221
Basic Information
- Device Name
- HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE)
- K Number
- K090563
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- INSTRUMENTATION LABORATORY CO.
- Date Received
- March 2, 2009
- Decision Date
- October 9, 2009
- 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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