JQC — Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use Class I
FDA Device Classification
Classification Details
- Product Code
- JQC
- Device Class
- Class I
- Regulation Number
- 862.2050
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K183205 | emcyte corporation | PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiol | May 30, 2019 |
| K103340 | harvest technologies | SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM | December 6, 2010 |
| K081345 | thermogenesis | AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY) | July 10, 2008 |
| K071934 | biomet manufacturing | MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT | October 11, 2007 |
| K070666 | perfusion partners and assoc | GENESISCS COMPONENT CONCENTRATING SYSTEM | June 20, 2007 |
| K052925 | harvest technologies | SMARTPREP2 CENTRIFUGE SYSTEM | January 4, 2006 |
| K042473 | cobe cardiovascular | COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM | November 19, 2004 |
| K024080 | perfusion partners and assoc | SECQUIRE CELL SEPARATOR | July 2, 2003 |
| K030555 | biomet | GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A | April 11, 2003 |
| K030340 | cytomedix | AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129) | April 11, 2003 |
| K021902 | medtronic vascular | MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPA | August 12, 2002 |
| K994148 | implant innovations | 3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM | February 1, 2000 |
| K991430 | harvest technologies | SMARTPREP CENTRIFUGE SYSTEM | May 28, 1999 |
| K944738 | ducker cl | SERIES 600 CENTRIFUGE-FOUR SEPARATE VARIATIONS OF THE SAME BASE CENTRIFUGE | October 19, 1994 |
| K881254 | norfolk scientific | STATSPIN DISPOSABLE ROTOR, PRODUCT #RD01 | April 5, 1988 |
| K864974 | norfolk scientific | GENERAL PURPOSE CENTRIFUGE | January 9, 1987 |
| K861146 | jouan | MODEL K110SX CENTRIFUGE | May 5, 1986 |
| K860747 | e.i. dupont de nemours and co | DU PONT SORVALL CENTRIFUGES (RAPIDSPIN R) | April 14, 1986 |
| K860172 | norfolk scientific | QWIKSPIN (TM) | February 11, 1986 |
| K850485 | e.i. dupont de nemours and co | ROTOR SYSTEMS A/S-400 & LA/S-400 | March 12, 1985 |