TransFix/EDTA Vacuum Blood Collection Tubes
FDA 510(k) clearance K162723 · decided 2017-06-22
Clearance details
- K-number
- K162723
- Device name
- TransFix/EDTA Vacuum Blood Collection Tubes
- Applicant
- Caltag Medsystems, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2016-09-29
- Decision date
- 2017-06-22
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- GIM
- Device class
- 2
- Regulation number
- 862.1675
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Buckingham, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.