510(k) K032952
K032952 is an FDA 510(k) premarket notification submitted by Sienco, Inc. for the device "AIACT KIT". The FDA issued a decision of Substantially Equivalent on December 12, 2003. The device falls under product code JBP (Activated Whole Blood Clotting Time), a Class II device regulated under 21 CFR 864.7140. Sienco, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 12, 2003
- Date Received
- September 22, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Activated Whole Blood Clotting Time
- Device Class
- Class II
- Regulation Number
- 864.7140
- Review Panel
- HE
- Submission Type