The following data is part of a premarket notification filed by Harvest Technologies, Corp. with the FDA for Smartprep2 Centrifuge System.
| Device ID | K052925 |
| 510k Number | K052925 |
| Device Name: | SMARTPREP2 CENTRIFUGE SYSTEM |
| Classification | Centrifuges (micro, Ultra, Refrigerated) For Clinical Use |
| Applicant | HARVEST TECHNOLOGIES, CORP. 40 GRISSOM RD Plymouth, MA 02360 |
| Contact | John D Bonasera |
| Correspondent | John D Bonasera HARVEST TECHNOLOGIES, CORP. 40 GRISSOM RD Plymouth, MA 02360 |
| Product Code | JQC |
| CFR Regulation Number | 862.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-18 |
| Decision Date | 2006-01-04 |
| Summary: | summary |