Product code JQC
- Device name
- Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.2050
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K183205 | PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System | Emcyte Corporation | 2019-05-30 |
| K103340 | SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM | Harvest Technologies, Corp. | 2010-12-06 |
| K081345 | AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY) | Thermogenesis Corp. | 2008-07-10 |
| K071934 | MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT | Biomet Manufacturing Corp | 2007-10-11 |
| K070666 | GENESISCS COMPONENT CONCENTRATING SYSTEM | Perfusion Partners & Assoc., Inc. | 2007-06-20 |
| K052925 | SMARTPREP2 CENTRIFUGE SYSTEM | Harvest Technologies, Corp. | 2006-01-04 |
| K042473 | COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM | Cobe Cardiovascular, Inc. | 2004-11-19 |
| K024080 | SECQUIRE CELL SEPARATOR | Perfusion Partners & Assoc., Inc. | 2003-07-02 |
| K030340 | AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129) | Cytomedix | 2003-04-11 |
| K030555 | GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A | Biomet, Inc. | 2003-04-11 |
| K021902 | MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300 | Medtronic Vascular | 2002-08-12 |
| K994148 | 3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM | Implant Innovations, Inc. | 2000-02-01 |
| K991430 | SMARTPREP CENTRIFUGE SYSTEM | Harvest Technologies, LLC | 1999-05-28 |
| K944738 | SERIES 600 CENTRIFUGE-FOUR SEPARATE VARIATIONS OF THE SAME BASE CENTRIFUGE | Ducker CL | 1994-10-19 |
| K881254 | STATSPIN DISPOSABLE ROTOR, PRODUCT #RD01 | Norfolk Scientific, Inc. | 1988-04-05 |
| K864974 | GENERAL PURPOSE CENTRIFUGE | Norfolk Scientific, Inc. | 1987-01-09 |
| K861146 | MODEL K110SX CENTRIFUGE | Jouan S.A. | 1986-05-05 |
| K860747 | DU PONT SORVALL CENTRIFUGES (RAPIDSPIN R) | E.I. Dupont DE Nemours & Co., Inc. | 1986-04-14 |
| K860172 | QWIKSPIN (TM) | Norfolk Scientific, Inc. | 1986-02-11 |
| K850485 | ROTOR SYSTEMS A/S-400 & LA/S-400 | E.I. Dupont DE Nemours & Co., Inc. | 1985-03-12 |
| K843434 | ISO-DATA CENTRIFUGES 1-A, 101, 2D, ETC. | Iso-Data, Inc. | 1984-10-05 |
| K843087 | UNIVERSAL 2 S CENTRIFUGE | Boehringer Mannheim Corp. | 1984-08-29 |
| K843088 | EBA 3 S CENTRIFUGE | Boehringer Mannheim Corp. | 1984-08-29 |
| K840768 | CENTRIFUGES | Heraeus-Christ GmbH | 1984-05-07 |
| K831942 | LKB 2164 MACRO-SPIN R CENTRIFUGE | Lkb Instruments, Inc. | 1983-07-29 |
| K831947 | LKB 2160 MIDISPIN CENTRIFUGE | Lkb Instruments, Inc. | 1983-07-29 |
| K831948 | LKB 2161 MIDISPIN R CENTRIFUGE | Lkb Instruments, Inc. | 1983-07-29 |
| K822715 | PLATELET CENTRIFUGE | Biodynamics Corp. | 1982-09-30 |
| K822422 | BASIC CENTRIFUGE | Biodynamics Corp. | 1982-09-02 |
| K821756 | IEC CENTRA 4 CENTRIFUGE | International Equipment Co. | 1982-06-25 |
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| 10850044310422 | Fisher Scientific | Thermo Electron LED GmbH | 2026-04-22 |
| 10850044310323 | Fisher Scientific | Thermo Electron LED GmbH | 2026-04-22 |
| 10850044310347 | Fisher Scientific | Thermo Electron LED GmbH | 2026-04-22 |
| 10850044310354 | Fisher Scientific | Thermo Electron LED GmbH | 2026-04-22 |
| 10850044310224 | Thermo Scientific | Thermo Electron LED GmbH | 2026-04-02 |
| 10850044310248 | Thermo Scientific | Thermo Electron LED GmbH | 2026-04-02 |
| 08800080220013 | ACS Combo-A Centrifuge | BSL Co.,Ltd | 2025-11-12 |
| 10850044310064 | Thermo Scientific | Thermo Electron LED GmbH | 2025-11-04 |
| 10850044310088 | Thermo Scientific | Thermo Electron LED GmbH | 2025-11-03 |
| 10850044310101 | Thermo Scientific | Thermo Electron LED GmbH | 2025-11-03 |
| 10850044310125 | Thermo Scientific | Thermo Electron LED GmbH | 2025-11-03 |
| 10850044310217 | Thermo Scientific | Thermo Electron LED GmbH | 2025-11-03 |
| 10850044310231 | Thermo Scientific | Thermo Electron LED GmbH | 2025-11-03 |
| M896AMS3160 | Magellan Complete One Source Kit | Arteriocyte Medical Systems, Inc. | 2020-03-04 |
| M896AMS3140 | Magellan Complete One Source Kit | Arteriocyte Medical Systems, Inc. | 2017-05-29 |
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| 07640125650303 | Regenerative medicine-Single-use kits | Biosafe S.A. | 2017-01-13 |
| 07640125650280 | Regenerative medicine-Single-use kits | Biosafe S.A. | 2017-01-13 |
| 07640125650099 | Sepax single-use kit | Biosafe S.A. | 2016-09-18 |
| 07640125650075 | Regenerative medicine-Single-use kits | Biosafe S.A. | 2016-09-18 |
| M896AMS3000 | Magellan Complete Disposable Kit | Arteriocyte Medical Systems, Inc. | 2016-09-12 |
| M896AMS3050 | Magellan Basic disposable kit | Arteriocyte Medical Systems, Inc. | 2016-09-12 |
| M896AMS3100 | Magellan Complete One Source Kit | Arteriocyte Medical Systems, Inc. | 2016-09-12 |
| M896AMS3120 | Magellan Complete One Source Kit | Arteriocyte Medical Systems, Inc. | 2016-09-12 |
| M89640K1000010 | Magellan Surgical tools for erythrocyte & marrow preparation kit | Arteriocyte Medical Systems, Inc. | 2016-09-12 |
| M896AMS5000 | Magellan Sterile cup kit | Arteriocyte Medical Systems, Inc. | 2016-09-12 |
| M896AMS1000 | Magellan Autologous Platelet Separator System | Arteriocyte Medical Systems, Inc. | 2016-09-09 |