510(k) K093910
K093910 is an FDA 510(k) premarket notification submitted by Guangzhou Improve Medical Instruments Co., Ltd. for the device "IMPROVACUTER GEL & CLOT ACTIVATOR TUBE". The FDA issued a decision of Substantially Equivalent on July 12, 2010. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Guangzhou Improve Medical Instruments Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 12, 2010
- Date Received
- December 22, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubes, Vials, Systems, Serum Separators, Blood Collection
- Device Class
- Class II
- Regulation Number
- 862.1675
- Review Panel
- CH
- Submission Type