FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM
K Number: K093243
·
Decision Apr 7, 2010
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
126
Applicant Total
3
Review Days
174
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Basic Information
- Device Name
- COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM
- K Number
- K093243
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7750
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Coagusense, Inc.
- Date Received
- October 15, 2009
- Decision Date
- April 7, 2010
- Product Code
- GJS
- 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 |
|---|---|---|---|
| GJS | Test, Time, Prothrombin | FDA class 2 | Hematology |
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