SMARTPREP2 Centrifuge System
FDA 510(k) K052925 · Harvest Technologies, Corp.
510(k) numberK052925
Submission
- Device name
- SMARTPREP2 Centrifuge System
- Applicant
- Harvest Technologies, Corp.
Plymouth, MA, US - Received
- October 18, 2005
- Decision date
- January 4, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JQC – Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2050
- Specialty
- Clinical Chemistry
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| K121005 | Adiprep Adipose Transfer SystemMUU · Traditional | 09/21/2012SE |
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| K043261 | Harvest Graft Delivery SyringeFMF · Traditional | 03/11/2005SE |
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| K011032 | Smartjet Bone Graft Liquid Applicator (Spray Tip), Model Sk/S, Smartjet Bone Graft…LYC · Traditional | 07/03/2001SE |
| K000456 | Harvest Technologies Dual Liquid Applicator, Model Sk/S: Harvest Dual Liquid Applicator…FMF · Traditional | 06/01/2000SE |
| K991430 | Smartprep Centrifuge SystemJQC · Traditional | 05/28/1999SE |
| K983022 | Smartcell Processing SystemCAC · Traditional | 04/02/1999SE |
Questions and answers
When was SMARTPREP2 Centrifuge System cleared by the FDA?
SMARTPREP2 Centrifuge System (K052925) received a 510(k) decision of Substantially Equivalent on January 4, 2006, 78 days after the submission was received.
What is the product code of K052925?
The FDA product code is JQC – Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2050.