ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136
FDA 510(k) clearance K062025 · decided 2007-05-29
Clearance details
- K-number
- K062025
- Device name
- ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136
- Applicant
- Corgenix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-07-18
- Decision date
- 2007-05-29
- Days to decision
- 315 days
- Clearance type
- Traditional
- Product code
- OBW
- Device class
- 2
- Regulation number
- 864.5700
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Broomfield, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.