The following data is part of a premarket notification filed by Harvest Technologies, Llc. with the FDA for Smartprep Centrifuge System.
| Device ID | K991430 |
| 510k Number | K991430 |
| Device Name: | SMARTPREP CENTRIFUGE SYSTEM |
| Classification | Centrifuges (micro, Ultra, Refrigerated) For Clinical Use |
| Applicant | HARVEST TECHNOLOGIES, LLC. 77 ACCORD PARK DR. D-7 Norwell, MA 02061 |
| Contact | Rick Lariviere |
| Correspondent | Rick Lariviere HARVEST TECHNOLOGIES, LLC. 77 ACCORD PARK DR. D-7 Norwell, MA 02061 |
| Product Code | JQC |
| CFR Regulation Number | 862.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-26 |
| Decision Date | 1999-05-28 |
| Summary: | summary |