510(k) K052925
K052925 is an FDA 510(k) premarket notification submitted by Harvest Technologies, Corp. for the device "SMARTPREP2 CENTRIFUGE SYSTEM". The FDA issued a decision of Substantially Equivalent on January 4, 2006. The device falls under product code JQC (Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use), a Class I device regulated under 21 CFR 862.2050. Harvest Technologies, Corp. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 4, 2006
- Date Received
- October 18, 2005
- Clearance Type
- Traditional
- 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