RAPIDTEG TEG-ACT TEST
FDA 510(k) clearance K062604 · decided 2007-01-31
Clearance details
- K-number
- K062604
- Device name
- RAPIDTEG TEG-ACT TEST
- Applicant
- Haemoscope Corp.
- Decision
- Substantially Equivalent
- Date received
- 2006-09-01
- Decision date
- 2007-01-31
- Days to decision
- 152 days
- Clearance type
- Traditional
- Product code
- JBP
- Device class
- 2
- Regulation number
- 864.7140
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Niles, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.