510(k) K081345
K081345 is an FDA 510(k) premarket notification submitted by Thermogenesis Corp. for the device "AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY)". The FDA issued a decision of SN on July 10, 2008. The device falls under product code JQC (Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use), a Class I device regulated under 21 CFR 862.2050. Thermogenesis Corp. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- July 10, 2008
- Date Received
- May 14, 2008
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2050
- Review Panel
- CH
- Submission Type