INRATIO/INRATIO2 TEST STRIPS
FDA 510(k) clearance K092987 · decided 2010-06-11
Clearance details
- K-number
- K092987
- Device name
- INRATIO/INRATIO2 TEST STRIPS
- Applicant
- Biosite Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2009-09-28
- Decision date
- 2010-06-11
- Days to decision
- 256 days
- Clearance type
- Traditional
- Product code
- GJS
- Device class
- 2
- Regulation number
- 864.7750
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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