510(k) K080552
K080552 is an FDA 510(k) premarket notification submitted by Streck for the device "CYTO-CHEX BCT". The FDA issued a decision of Substantially Equivalent on July 31, 2008. The device falls under product code GIM (Tubes, Vacuum Sample, With Anticoagulant), a Class II device regulated under 21 CFR 862.1675. Streck has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 31, 2008
- Date Received
- February 28, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubes, Vacuum Sample, With Anticoagulant
- Device Class
- Class II
- Regulation Number
- 862.1675
- Review Panel
- CH
- Submission Type